NOTICE: This document contains references to Varian.

Please note that Varian, Inc. is now part of Agilent Varian, Inc.
Technologies. For more information, go to 2700 Mitchell Drive
www.agilent.com/chem. Walnut Creek, CA 94598-1675/USA

Varian Workstation
Access Control and Audit Trail Software

Setup and Documentation Manual

©Varian, Inc. 2002 Printed in the U.S.A. 03-914942-00:3

 Table of Contents
Section 1 - Overview ___________________________________________________3
Manual Outline ______________________________________________________3
How to use the Varian Access Control and Audit Trail Manual Set ___________4
Section 2 - Factory Validation of Access Control and Audit Trail Software ______5
Section 3 - On site Validation of Varian workstation software including Access
Control and Audit Trail Software _________________________________________6
Section 4 – Varian workstations and 21 CFR 11 regulations __________________7
Section 5 - Sample Standard Operating Procedures (SOPs) __________________8
Policies ____________________________________________________________8
Procedures ________________________________________________________10
Section 6 – Access Control and Audit Trail Software Training Materials. _______11
Self - Learning Course_______________________________________________11
Section 7 - Getting Started _____________________________________________13
Appendix 1 – Factory Validation Plan ____________________________________17
Appendix 2 – Suggested on Site Validation Procedures for Varian Access Control
and Audit Trail Software. ______________________________________________56
Appendix 3 – Comparison of Varian workstations with Access Control and Audit
Trail (AC&AT) software to 21 CFR 11 regulations __________________________57
Appendix 4 – Tests for the Administrator course for Varian Access Control and
Audit Trail software. __________________________________________________65
Test for lesson 1____________________________________________________66
Test for lesson 2____________________________________________________68
Test for Lesson 3 ___________________________________________________70
Test for Lesson 4 ___________________________________________________72
Answers for Tests 1 through 4 ________________________________________74
Appendix 5 - Forms for Getting Started to set up Security Administration Software
____________________________________________________________________75
Form A – Selecting the Local Workstation for Standalone or Network Operation.
__________________________________________________________________75
Form B – Entering Policies using the Policy page ________________________76
Form C – Workstation and Instrument Entry Form________________________77
Form D – Project Entry and Instrument Association Form _________________78

Access Control and Audit Trail Software 1 03-914942-00:3

 Form E – Reason Entry Form _________________________________________79
Form F – Individual user information Entry Form_________________________80
Form G – User Groups_______________________________________________81
Form H – User or Groups/Project Rights Entry Form______________________82
Software Certificate Of Compliance______________________________________83

Access Control and Audit Trail Software 2 03-914942-00:3

Section 1 - Overview
Software alone cannot provide compliance with the regulations on electronic records and electronic
signatures (21 CFR 11). Other documentation is needed. This manual provides much of this
documentation. It also provides help in creating documentation that the user must provide.

Manual Outline
This manual is divided into 7 sections:

Section 1 is an overview of the manual. It also provides an outline of what the Access Control and
Audit Trail software system administrator should do to get the system running correctly.

Section 2 is a description of the factory validation test plan that was used to validate the Access
Control and Audit Trail software. (The detailed test plan is in Appendix 1.) The core workstation
software including data handling and instrument control for both chromatography and mass
spectrometry has been validated previously.

Section 3 is a description of how to validate the software on-site. This includes a validation program
that checks each file for changes from the files that were shipped from Varian Inc. There are also
some suggested tests that can be done in the field to perform a limited validation on the product. A
“mini” test plan is detailed in Appendix 2.

Section 4 is a description of how the Access Control and Audit Trail software helps the user meet
the requirements in 21 CFR 11 regulations. A detailed comparison of the functionality of the software
to the individual clauses is given in Appendix 3. This table can be used to demonstrate how this
software addresses the regulations.

Section 5 contains material that should be written into Standard Operating Procedures (SOPs).
These SOPs should standardize the operation of the Access Control and Audit Trail software, as well
as how new users are entered and user information updated.

Section 6 contains course material and certification tests that can be used as a self-learning
program which a workstation administrator can take in order to learn how the system functions. This
can also be used by a trained Varian service representative to teach users how to act as workstation
administrators for the Access Control and Audit Trail software. The certification tests and answers
are in Appendix 4.

Section 7 is a step-by-step procedure for getting started with the Access Control and Audit Trail
software. This takes the user through the initial configuration of a single or multi-workstation system
and the entry of all of the relevant data for workstations, instruments, users, groups, and projects.
Appendix 5 contains forms to gather the required information.

Access Control and Audit Trail Software 3 03-914942-00:3

How to use the Varian Access Control and Audit Trail Manual Set
The Access Control and Audit Trail software is documented in a two-manual set that contains all of
the information that you will need to run and administer this software. This software supports both
the Varian Star and MS workstations. If you are not familiar with the operation of the type of
workstation that you have, please see the workstation manuals and tutorials on the workstation CDs.
You do not need to know how to operate the workstations in order to be a workstation administrator
for the Access Control and Audit Trail software.

This manual, the Setup and Documentation manual, should be used as a step-by-step guide for
getting started with the use of this software option.

The Access Control and Audit Trail Software Operation manual should be used as a reference
manual. It describes what each entry means and what the legal inputs are for each entry. If you are
uncertain about an entry while going through this manual, please refer to the Operation manual for
more information. In addition to detailed information about individual entries, the Operation manual
contains the following information:

1. An explanation of the software itself, how it is organized, and how to use it. This information is
used as part of the self-learning course that is contained in this manual for the Access Control
and Audit Trail software.

2. Definitions of terms used by these manuals.

3. A brief comparison of the Star and MS workstation software that explains how they are similar,
how they are different, and how this relates to the Access Control and Audit Trail software.

Access Control and Audit Trail Software 4 03-914942-00:3

Section 2 - Factory Validation of Access Control and Audit
Trail Software
We have extensively tested the Access Control and Audit Trail software with the Star and MS
workstations. This documentation applies to Version 6.30 and above. We have previously validated
the operation and calculations of the core software for both the Star and MS workstations. We have
included a copy of the software certificate of validation (see page 83) confirming that this software
has been fully evaluated. Results from the actual validation are permanently kept at CSB in Walnut
Creek, California, U. S. A. A copy of the test plan that was used to validate this software is in
Appendix 1. Note: general terms such as workstation and Varian workstation are used in this manual
to refer to both the Star and MS workstations.

Access Control and Audit Trail Software 5 03-914942-00:3

Section 3 - On site Validation of Varian workstation software
including Access Control and Audit Trail Software
This software can be validated on-site and during its operation. Software validation can be divided
into three parts: the validation program, validating operation through a test plan, and long-term
validation.

The Varian workstation software has a validate program that verifies that the checksum of each
executable file of the workstation matches the checksum of what was tested in the factory. Each
software version has its own unique list of checksums. These checksums are included in a file
installed with the workstation. Once the software is installed and any time afterwards, run the
validate program to check the software (the Validate Installed Files function is available from the
‘About box’ in all workstation applications, and from the workstation menu under Program Files).

The workstation software itself has procedures, methods and test files to validate its data handling
and calculation algorithms. The algorithms used for all calculations in Star software are detailed in
the Regulatory Compliance manual on the Star CD. These should be used if it is necessary to
validate the calculation software on-site.

Because the Access Control and Audit Trail option for Varian workstation software does not contain
any specific data manipulation calculations, it should not be necessary to validate this software at the
customer’s site. If the customer feels that it is necessary to do some testing on-site, some of the
procedures described in the factory validation test plan can be used. However, all of the tests should
not be used, as this would be very time consuming. Appendix 2 has a list of the sections of the
factory test plan that might be used to do a shortened file validation procedure.

Access Control and Audit Trail Software 6 03-914942-00:3

Section 4 – Varian Workstations and 21 CFR 11 Regulations
To make it easier to document that the Access Control and Audit Trail software provides the tools for
meeting the requirements outlined in 21 CFR 11, a table that compares the regulations with the
capabilities of the software is provided in Appendix 3.

Access Control and Audit Trail Software 7 03-914942-00:3

Section 5 - Sample Standard Operating Procedures (SOPs)
The Varian Access Control and Audit Trail software alone cannot meet the FDA requirements for
compliance with 21 CFR 11. Laboratory SOPs are needed to insure that the software is used
properly. These SOPs fall into two categories: policies and operational procedures. The policies and
procedures listed below are those that we suggest should be covered by SOPs. Other SOPs can be
written to cover other parts of the software.

Policies
The Access Control and Audit Trail software requires that certain policies be set for compliance with
21 CFR 11 regulations. These policies should be documented in one or more laboratory SOPs so
that software functionality is consistent even when different individuals act as administrators. The
policies that should be set in SOPs are listed below with explanations.

SOP Policies Explanation

Enable Login This is not required by the regulations. If you do not check the box, the
Dialog Timeout login will stay on the screen until someone makes an entry or presses
“Cancel”. This is a matter of preference.
Disable Accounts This is required by the regulations, so it should be checked.
After Password
Tries
Password: Retries This is required by the regulation, but the number of retries is not
stated. This should be set to a reasonable number so that, if someone
has two or three passwords for different systems, they will not disable
their login if they enter the wrong one. Somewhere between 3 and 6 is
a good value.
Password: It is good practice to set a large enough minimum length that someone
Minimum Length cannot find out another person’s password by trial and error. However,
do not set it so high that users have a hard time figuring out a
password that is both long enough and that they can remember.
Practically, between 6 and 10 is a good range for this.
Password: This entry is to prevent users from just using their own name as a
Minimum Numeric password. Your own name is too easy for someone to guess. By
Characters adding some numbers to the password, it will be harder to guess
someone’s password. Practically, 1 to 3 is a good range for this.

Access Control and Audit Trail Software 8 03-914942-00:3

 SOP Policies Explanation
Password: Default The regulations require that passwords be protected from aging. Each
Expiration (Days) user must change their password periodically. There is no mention as
to how long. 90 days should be a minimum as it would be difficult to
keep track of passwords that changed more often than that. 365 days
should be a maximum as changing passwords at least once per year
would be good. Note: this is only a default setting. Individuals could
get an individual length for their password expiration by changing the
setting on the Users entry page. In general, it is best that each
person’s password expiration is kept the same.
Application The regulations state that the system should prevent someone else
Timeout from performing activities under another person’s login. Without an
application timeout, one person could leave the workstation and
someone else could use his or her login. Choosing a good application
timeout requires an understanding of how the laboratory works. If the
workstation is basically used by one person all of the time and they
spend a lot of time setting up automated runs etc., then a long timeout
such as 600 seconds might be appropriate. If many people use the
instrumentation, then a shorter timeout such as 120 seconds would be
more appropriate. This application timeout will apply to every
workstation on a networked system, so it should be chosen carefully.
Audit Log Warning A policy should be set as to how often to archive the system log and
the security server audit log. The security audit log for the
administration software will grow larger initially when the system is first
installed. Later it will grow only when individual entries in the security
database are changed or when Alarms occur. A size limitation would
be best for the security audit log. Once it gets too big (e.g. >1 Mbyte),
it should be archived. The system log will grow quickly as work is done
in the lab. A time limit for this log would be best. The system log is
automatically archived when it reaches its limit, either in time or size.
Archive Folder The archive folder is the location of the security audit log. If the system
is networked, this should be on the workstation that contains the
security database.
User Information The regulations say that each individual using the system must be
clearly identified. The best way to do this is to enter some amount of
user information beyond the user’s name. This user information could
include their company identification number, department name or
number, job title or role, or other information. The information that is
required should be put into an SOP.
The Global Project Rights on the global project should be carefully assigned, because
those rights apply to all projects, all workstations and all instruments. If
a user has the right to run samples on the global project, they can do
this on any workstation and any instrument in the system. In general, it
is good policy to assign rights on a project basis. Only the activities of
acting as a system administrator, system maintenance or unlocking
private locks must be assigned on the global project.

Access Control and Audit Trail Software 9 03-914942-00:3

Procedures
Besides policies, procedures should be set for the lab in order to comply with the regulations. Some
of the procedures that are needed are listed below.

Entering a New User

When the system is first installed, and periodically as individuals come to work in the lab, the system
administrator will have to add people to the system. The regulation states that the administrator
cannot know both the user’s login name and password. However, because each person must be
clearly identified, the administrator will have to know the user’s login name. Therefore, their
password must be unknown to the administrator.

There are two ways to do this. One is to create a user name and a standard password. This will
always be the same initial password. The user will then be told to go to a workstation, login with their
new login name and password, and then change their password. This should be done immediately.
This would be good for the initial configuration of the system.

Alternatively, if the new user were present while the administrator was entering them into the security
database, they could enter their own password on the Users information page. This is more efficient
when new people are being added to an existing system.

Changing the Default Password

When you first log on to the administration software, a default login (Admin) and password (Chrom)
are used. That login name cannot be deleted from the system. It is always there as a protection in
case the administrator is locked out of the system. However, the default password should not be left
as-is because the system will not be secure. The password for the default login should be changed
after the first administrator is logged in and has a password. This can be changed to anything that
follows the password rules. The password should be written down and secured in a safe location so
that, if it has to be used, it is available.

Open Dialog Boxes

If dialog boxes are open when you log out, it is possible for someone else to add or modify the
information. You should set a lab SOP that states to close all open dialog boxes.

Access Control and Audit Trail Software 10 03-914942-00:3

Section 6 – Access Control and Audit Trail Software Training
Materials
Learning about the Varian workstation software before operating it will make operation for the first-
time user much easier. If a user is familiar with the operation of Star 5.x software, then the current
version will be easy to operate as very little has changed in the core software. You can review the
information about what has changed in product release notes and in the Access Control and Audit
Trail software Operation manual. If a user has never worked with the Varian workstation software
before, then the tutorials on the workstation CDs will be very helpful in getting to know the system.
The current MS workstation software has changed more significantly from its previous 5.x versions. If
your system will include MS workstations, it is recommended that you familiarize yourself with the
new software.

The most significant changes to the operation of the workstation software when it is used with the
Access Control and Audit Trail Software are contained in the Security Administration program. For
the users of the workstation, these changes are minimal. Their main interaction with the new
software will be logging in, working with the method and data file embedded versions, and dealing
with private locks. In order to learn to work with these features, they should review the following
sections in the Operation manual:
1. Method File Audit Trail
2. Data File Audit Trail
3. Controlling Access to the Workstation Software
Anyone who will act as an administrator of the Access Control and Audit Trail software will need
more comprehensive training. Among other things, a workstation administrator will have to learn how
to create and modify the security database, how to archive audit logs, how to create new users,
groups, workstations, projects and reasons, and how to clear alerts.

In order to gain this understanding, the workstation administrator should take a course either from a
Varian representative trained in the software or through the self-learning course listed below. The
self-learning course focuses on reading the Operation manual and taking tests on the material. It
culminates in the initial preparation for configuring the system for operation and then logging on for
the first time. A course from a Varian representative will follow the same approach. The advantage of
taking the course from a Varian representative is that the user will have the opportunity to ask
questions about the material.

Note: The self-learning course requires that someone other than the person taking the course
administer and grade the tests. Because the tests are multiple choice and the answers
are given in Appendix 6, the person administering the course does not have to be
knowledgeable about the product.

Self - Learning Course

The self-learning course is designed to prepare the system administrator to set up a Varian
workstation system with Access Control and Audit Trail software. The course consists of reading
assignments and multiple-choice tests. The procedure to take the course is as follows:

1. Make copies of all the tests in Appendix 6 so that the originals are available for
subsequent training courses.
2. Read the assigned sections of the manual.
3. Take the test listed in Appendix 4 for that section.

Access Control and Audit Trail Software 11 03-914942-00:3

 4. Have someone else grade the test using the answer key in Appendix 4.
5. If you got at least 12 of 15 correct (80%), the person grading the test should report
which questions you got wrong and what the correct answers were.
6. If you got less the 12 correct (less than 80%), review the material and retake the test.
The person administering the course should not report which answers were wrong.
7. Once you have gotten 80% or more correct on any test, go to the next section.
8. Once you have passed a lesson, fill out the score on the form in Appendix 6.
9. When you are done with all of the sections, go to section 7 in this manual and begin
setting up your workstation or workstation network. Going through this self-learning
course is step 1 of the getting started procedure.

Lesson and test# Reading sections

1 Operation Manual
Introduction
Software System Description
Overview Of Varian Access Control And Audit Trail Software
Security Administration Software
Overview Of The Security Administration Software
The Security Administration Software
Policy/Sessions Page
2 Operation Manual
Security Administration Software
Users Page
Groups Page
Workstations Page
Instruments Page
Projects/Reasons Pages
Rights Checks Page
3 Operation Manual
Workstation Software
Comparison Of Star And MS Workstation Software
File Security
Overview Of Logs Method File Audit Trail
Data File Audit Trail
Security Server Audit Log
System Log
Message Log
Controlling Access To The Workstation Software
4 Setup And Documentation Manual
Section 1 Through Section 5

Access Control and Audit Trail Software 12 03-914942-00:3

Section 7 - Getting Started
After the Varian workstation and Access Control and Audit Trail software is installed on one or more
PCs, it is necessary to decide how the system will be configured and to set up the security server
and database. The following is a step-by-step procedure for doing this. If you follow these steps, the
system will operate as you want it to.

There is a series of forms in Appendix 5 to help you organize the information needed to set up the
Security Administration program and security database. One type of form will be printouts of actual
screens that have been enlarged and modified so that you can hand enter information directly into
them. When you enter the information into the system, you can read it directly from the form. An
example of this is shown in the figure below:

Figure 1 Example of Entering Information into a Screen Form

Another type of form is a table form. This type of form is used when it is necessary to make multiple
entries into a section of the software. There are several examples of these in the Appendix.

DO NOT WRITE DIRECTLY ON THE ORIGINAL FORMS. MAKE ENOUGH COPIES OF THESE
FORMS SO THAT YOU CAN ENTER ALL OF THE INFORMATION INITIALLY NEEDED FOR THE
SYSTEM.

Steps 2 through 11 are decisions that you will want to make BEFORE you enter anything in the
security administration software and security database on the workstation. Steps 12 to 25 are the
steps that you will take to enter the data that you have created. The order of deciding on the data is
different than the order that you will use to enter it into the security server.
Step 1: Take the “Access Control and Audit Trail Software” course. This can either be from the
Varian customer support representative who installs your system or through the self-
teaching course described in section 7 of this manual. Take all of the tests and have
them graded. If you answer at least 80% of the questions correctly, you will be ready to
configure the system.

Access Control and Audit Trail Software 13 03-914942-00:3

 Part 1: Deciding What Entries to Make in the Security Database
Step 2: There are several decisions that you will want to make before you start setting up the
security database. The first is most important. If there is only 1 workstation that will be
using this software, you will configure the security server, the security database, and the
security audit log to be located on that PC. Do this on the Workstations page (Form A) by
checking the button for standalone operation.
If you want several workstations to share the same security server, security database and
security log, then you will configure one workstation for standalone operation and the
other workstations to use a security server by checking the radio button “Use a security
server” (Form A). Any workstation can be used as the security server (the workstation
configured for standalone operation) as long as it is always powered on and running. The
security server does not need to be on a network server although it can be. Once you
have configured the workstation that will be used for standalone operation, all of the other
workstations should refer to the workstation either by its IP address or by its name on the
network.
If you are using a security server on the network, you must make the entries for the
initial configuration and setup from this workstation. (After you have done that,
you can change the configuration and information in the security database from
any other workstation.)
Step 3: You will want to decide on the entries that you will make before you begin configuring the
security database. In this way, you can minimize the amount of work necessary to set up
the system initially. All of the entries that you make now can be changed later. Some of
the entries should be controlled by SOPs for your lab, which are listed in section 5 of this
manual “Sample Standard Operating Procedures”. Please review the first section of
these SOPs concerning lab policies, in this manual. You can make these entries on Form
B. For detailed information about what each Policy entry means, please refer to the
Policy page entries of the Operation manual.
Step 4: Once you have set the policies for use of the workstations, you should decide on the
workstations, instruments, projects, users and groups that you want to enter initially into
the security data base. Workstations and the instruments associated with them should be
decided upon first. These are the actual workstations that will acquire information from
the security database. They should be given a name to help distinguish them in the
laboratory. When samples are run, the name given to the workstation will be permanently
attached to the data. Enter all of the workstations that you plan to have configured on this
security database on Form C (Workstation and Instrument entry form).
Once you have decided on workstations, you should decide on the names of the
individual instruments that will be attached to the workstations. If the workstations are
created from the server, 4 default instrument names will be created automatically for
each workstation, regardless of whether it is a single- or multi- instrument workstation, or
how many instruments actually exist on it. If the workstations are created at the individual
PCs, the administration software will detect whether that PC has single- or multi-
instrument software, and it will create either 1 or 4 default instrument names respectively.
In either case, when you go to the individual workstations, you should delete any
“excess” instruments from them.
The names of the instruments will be appended to any data generated on these
instruments. The default names, workstation name_1,2,3, or 4, can be used without
further modification. However, individual names may help identify the individual
instruments in the lab. The instrument names can be entered on the same form as the
workstation names.

Access Control and Audit Trail Software 14 03-914942-00:3

 Step 5: Next you should decide on the projects that will be used in your laboratory. Projects are
the way that the security server associates individual users and groups of users with
instruments. You create a list of these on the Projects page. You can enter these project
names on Form D.
Step 6: After creating the projects, you should associate them with the instruments that you have
decided on. One instrument can be associated with any number of projects and any
number of instruments can be associated with one project. This is also done on Form D.
Step 7: Once you have created projects, you should add Reasons that are appropriate for your
laboratory. You can do this on the Projects/Reasons page. There are preset reasons built
into the security server. You can keep these or you can delete them and enter any
reasons that you want. A worksheet for the reasons is located in Form E.
Step 8: The next step is to create identities for the individual users who will be using the system.
These individual identities will be entered in the Users page. Use Form F as a worksheet
for the individual user entries.
Step 9: Once you have created individual users, decide if there are several users that should
have the same rights. If you group users together, it can be easier to manage their rights.
Use Form G to create groups and add users to them.
Step 10: At this point, you should decide on the rights that individual users and groups of users
should receive. Keep in mind that rights are related to users through projects. A user has
a particular set of rights for a particular project. If you want a user to have the same rights
on all projects, you should assign the rights on the global project. Use Form H to
designate the rights for individual users and for groups.
Step 11: Finally, you should decide on a new password for the default login (admin). You should
write this down and save it in a secure place. If, for some reason, everyone with
administrator rights is deleted from or temporarily disabled on the security server, you will
need to log on with the admin login.

Part 2: Entering Information into the Security Database through the Security
Administration Software
Once you have completed all of the steps for the initial entry of information into the security
database, you are ready to begin entering information. The first to do is log in and create yourself as
an administrator user. You then will log out and log back in with your own identity. In this way, the
audit trail for the administration software will correctly identify who made the changes to the security
database.
Step 12: You should go to the workstation that will be used to hold the security database and log
onto the security administration software using the default login name (admin) and the
default password (chrom).
Step 13: Go to the Users page and create yourself as a user, enter your password twice, your full
name, and give yourself administrator rights. Save this new user and enter an
appropriate reason. Close the security administration software.
Step 14: On the workstation, log in using your own identification and password. The first thing you
should do is to add any reasons that you had decided to add, especially if you want to
use a particular reason while you are initially building the security database. Go to the
Reasons page and add the Reasons you added on Form E.
Step 15: On the same page as the Reasons, create the projects that you had previously entered
on Form D. You will have to enter a reason for each project.

Access Control and Audit Trail Software 15 03-914942-00:3

 Step 16: Go to the Workstations page. Since this is the standalone workstation, you will only need
to set the location of the workstation security file and the workstation log file. Those were
entered on Form A.
Step 17: On the Workstations page, identify by name the workstations that will be on the system. If
this is a single-PC system, then there will only be one workstation to identify. If there is
more than one PC using the security database, enter the workstation names from Form
C.
Step 18: Once you have entered all of the workstations, select the name of the workstation that
you are working on and “Apply ID” to it. This will uniquely identify this workstation. Later,
you will identify the other workstations in a similar manner.
Step 19: Move to the Instruments page and identify by name the instruments on each of the
workstations that you have created. When you created the workstations, default names
were created for all of the instruments. If you wish to accept them, then you need do
nothing. If you want to change some of them based on the information that you entered
into Form C, then do so here.
Step 20: After entering the names of all of the instruments, you will need to associate those
instruments with individual projects. Remember that they are automatically associated
with the global project. Enter the instrument and project associations that you previously
created on Form D.
Step 21: Go to the Policy page and enter the information here that you entered on Form B.
Step 22: Now go to the Users page and begin to enter the individual users as you have created
them on Form F. Depending on what SOPs you have set for entering individuals, you
may want to enter all of the individuals now and give the users preset passwords that
they can change later. Or you may want to have each of the individuals come to you and
enter their passwords when you create their identities. After an individual has been
created and their information has been entered, you can enter their rights as you set
them on Form H.
Step 23: If you have decided to create groups, go to the Groups page and create the groups that
you wish to have based on your entries on form G. Then associate the individuals you
want in each group, with that group. Once you have done that, give each group the rights
on each project that you have previously entered on Form H.
Step 24: Once you have done all of this, you can exit the security server software. If you are only
using one workstation, you are finished. If you are using multiple workstations on a
network, you will need to go to each of those workstations individually and identify the
security server that they will be using. To do this, you will log in to the security
administration software on the individual PC using the preset login and password. You
will then go to the Workstations Page and select the “Use security server” radio button.
Then enter the IP address or the NAME OF THE SECURITY SERVER ON THE
NETWORK. This is not necessarily the name that you gave the security server when you
created its name in the security server software. It is the name it has on the network. This
information can be obtained from the Network Administrator. When you have entered this
name, log out of the security server software.
Step 25: Now log in to the workstation on the same PC using your own name and password. If it is
not successful, the workstation could not find the security server. See your network
administrator for help in making sure that this workstation has access to the workstation
that you have designated as the security server. Once you have logged in, go to the
Workstations page. On the bottom of the page, select the name that you wish to assign to
this workstation. Once you have done that, click on apply ID. An identification number
should be applied. Once you have done this for all workstations associated with this
security server, you are done with the initial system configuration and ready to run the
workstation software.

Access Control and Audit Trail Software 16 03-914942-00:3

Appendix 1 – Factory Validation Plan
VARIAN CHROMATOGRAPHY SYSTEMS BUSINESS
LC RESEARCH

MEMORANDUM

TO: Distribution
FROM: Gary Burce

DATE: November 28, 2001

MEMO NO.:
SUBJECT: 21 CFR 11 test plan

Overview
Software testing for Star 6.0 will focus on the sections of the code that have changed from Star 5.52.
Most of the changes are in the area of access control and audit trails. The actual testing is divided into
three parts, user entry testing, operational testing and reliability testing.

In user entry testing, all of the possible entries the can be made to the software will be tested. Most of
them will be in the Security Administration section of the software. A wide range of entries will be tested
with a focus on the boundary conditions. Where entries interact, their interaction will be tested. (For
example, if the security server requires that 10 characters be present in all password, the system will be
checked to make sure that no newly entered passwords can contain less than 10 characters.) The
persistence of all entries will be tested.

In operational testing, the newly added functions of the Star version 6.0 will be tested. This will include
checking to see that access control is working properly, that audit trails are correctly created and that
changes to files are correct while the content of previous versions are preserved. This will also involve
testing the ancillary functions such as the version comparing software and the audit trail display and
archiving software.

In reliability testing, Star 6.0 with the security and access control operating will be tested with all of the
other modules running in automation to prove the reliability.

Star 6.0 will be tested and supported using Windows 2000 and Windows NT service pack 6. If possible,
minimal testing will be done with Windows NT service pack 4 and Windows 98 although Windows 98 will
not support security. Operation with Windows XP will not be tested at this time.

Adobe Acrobat 5.0 will be run at the same time as Star 6.0 in all systems used for testing to simulate how
customers will do electronic signatures. Acrobat 4.0 will not be tested.

Access Control and Audit Trail Software 17 03-914942-00:3

 Documentation and Software Release Procedure
The following procedure will be used with this test plan document:

1. Part, or all of the test plan, will be performed on each release of the software before the final
release of software.
2. The part of the test plan used will depend on the individual features available in the software and
what has been previously tested.
3. All defects, change requests, comments and observations about the software will be entered into
the Tracker database for 21 CFR 11.
4. The change control board will evaluate each entry into Tracker for its seriousness and assign it a
P1, P2, or P3 status with P1 meaning “must fix before shipment”, P2 meaning “desirable to fix but
not required” and P3 meaning “under consideration for changing in future versions of the
software”.
5. When a release candidate is created, all previously found defects listed in Tracker as P1 will be
rechecked whether they have been previously listed as repaired or not. In addition, everything in
this test plan will be checked on the release candidate. A release candidate will be approved only
when all of the test plan is complete and all of the P1 defects have been cleared.
6. When testing a release candidate, all of the entries in this test plan will be signed off and dated by
the evaluator, either electronically or manually. A copy of this final test plan is stored in the
product documentation for at least 5 years after product obsolescence per CSB procedure.
7. When a release candidate is approved, all P2 issues deemed important by the change control
board will be discussed in the release notes.
8. The basic functions of the workstation software that have not changed from the previous version
will not be explicitly checked. They will be tested to some extent while running the reliability
testing as described below. The core Star and MS workstation software is tested separately from
this test plan.

Glossary for the test plan:

NA Not applicable for this test
Pass The system should do the required task
Fail The system should not allow you to do the required task

Access Control and Audit Trail Software 18 03-914942-00:3

 User Entry Testing

Scope and Purpose

In the user entry testing section, the evaluation will test all of the user entries for the following:
1. Check all inputs to make sure that all valid inputs can be made.
2. Check all inputs to make sure that all invalid inputs are rejected.
3. Check all inputs to make sure that when inputs are made, they are effective.
4. Check all inputs to make sure that they are persistent.
5. Check all inputs to make sure that they cannot be duplicated.

The administration security server is the major change that has extensive user inputs. The user inputs
associated with this software will be checked as a separate part of the test plan. All of the other new
features have minimal user input changes. These will be checked as part of the operational testing.

Access Control and Audit Trail Software 19 03-914942-00:3

 Administration Security Server – Policy/Sessions Page
Entry Range of Input tests Pass Function tests Pass
values Date Date
Name Name
Enable Login Check and Check to see if the login
Yes/No
Dialog Timeout Uncheck. timeout actually works.
Disable Accounts Uncheck box, log in
After “Password Check and incorrectly set number of
Yes/No
Retries” Is Uncheck. times consecutively and
Exceeded unconsecutively.
Uncheck box, log in
Enter valid
incorrectly set number of
Password Retries 1 to 99 and invalid
times consecutively and
numbers.
unconsecutively.
Enter valid Enter valid numbers and test
Password
0 to 20 and invalid on next page for control of
Minimum Length
numbers. password length.
Password Enter valid Enter valid numbers and test
Minimum Numeric 0 to 20 and invalid on next page for control of
Characters numbers. password length.
Enter valid numbers, save
Enter valid changes, change date on
Password Default 0 and 1 to
and invalid computer, make sure
Expiration (Days) 999
numbers. password change is
prompted x days in advance.
Make sure that the
Application Enter valid
0 and 1 – workstation application
Timeout and invalid
999 timeout at the appropriate
(Seconds) entries.
time.
Enter more
User Information 31 Check boxes on next page
than 16
Titles characters for proper prompts.
characters.
Include In Check and
(Check) NA NA NA
Signatures Uncheck.
Click on and
Security Audit Log off and
Make sure audit log is
Warning Type – On/Off make sure
controlled by size.
Size entries are
grayed out.
Enter valid
1 – 9999 Make sure that the warning
Size and invalid
Kbytes comes up at the proper size.
numbers.
Click on and
Security Audit Log off and
Make sure that the date is
Warning Type - On/Off make sure
used for a warning.
Date entries are
grayed out.
Enter valid
Make sure that the warning
Number Of Days 1 - 999 and invalid
comes up at the proper date.
numbers.
Make sure
Next Archive that the
NA NA NA
Number entry is
correct.

Access Control and Audit Trail Software 20 03-914942-00:3

 Entry Range of Input tests Pass Function tests Pass
values Date Date
Name Name
Make sure
Any path
that only Make sure that the archive is
and folder
Archive Folder valid folders really stored in the
up to 260
are designated folder.
characters
accepted.
Browse For Make sure you can look for
Click NA NA
Archive Folder archive folders everywhere.
Make sure that the audit
Run Audit
(Press) NA NA maintenance utility is
Maintenance
displayed.
Make sure that the system
System Log
On/Off NA NA log is archived when its size
Maintenance -Size
limit is reached.
Make sure
System Log Make sure that the size
1 to 2550 only valid
Maintenance – limits are applied from the
K Bytes numbers are
Size Limit actual size.
entered.
System Log Make sure that the date is
Maintenance - On/Off NA used for logging the system
Date log.
Make sure
System Log only valid Make sure that the system is
Maintenance – 1 to 255 numbers backed up on the
Days can be appropriate day.
entered.
Check accepting and
Modify Policy (Press) NA NA rejecting modifications and
see if the policies change.
Make sure that the Policies page entries are not discarded when the application is exited. Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 21 03-914942-00:3

 Administration Security Server - Users Page Entries
Entry Range of Input Test Pass Function test Pass
Values Date Date
Name Name
Select A User Click on Check to see the user data
Click on user.
From List user in list appears.
Enter more
1 to 15
User Name than 16 Log in with name.
characters
characters.
Enter
Password 1-20 previously set Log in with password.
values.
Enter
previously set
Repeat Password 1-20 values and NA
different
entries.
Enter more
0 to 18
Full Name than 19 NA NA
characters
characters.
Last Password Date and
NA NA Check to see this is correct.
Changed Date time
Large Make sure number is created
UID NA NA
number and stays with user.
Change dates to make sure
account expires in those
Enter valid and
Password 0 and 1 to days.
invalid
Expiration (Days) 999 Change dates to make sure
numbers.
that a prompt appears 5 days
before the expiration date.
Make sure that the password
Current Enter valid and
count is incremented correctly
Password Failure 0 to 99 invalid
and that it can be reset from
Count numbers.
the page.
Make sure software cannot
Check and
Account Enabled (check) be accessed when account is
Uncheck.
disabled.
Make user new user created.
Create (Press) NA NA Make sure existing users are
not affected.
Make sure existing user is
Modify (Press) NA NA modified and new values are
saved.
Make sure existing user is
Remove (Press) NA NA
removed and cannot log in.
Make sure any of the logins
Test Login (Press) NA NA
can be tested.

Access Control and Audit Trail Software 22 03-914942-00:3

 Entry Range of Input Test Pass Function test Pass
Values Date Date
Name Name
Information tab
Enter variety
of values with
Specific 0 - 31 Make sure inputs stay with
some greater
Information characters user.
than 31
characters.
Enter variety
of values with
0 - 127 Make sure inputs stay with
Other Information some greater
characters user.
than 127
characters.
Rights Tab
Make sure all
Project Make sure rights entered stay
Select Project projects can
names with project.
be accessed.
System
Make sure user can access
Workstation
(Check) NA NA security server and perform
Administrator
all actions on it.
Perform System Make sure user can upgrade
(Check) NA NA
Maintenance software and save archives.
Make sure user can unlock
Unlock Private
(Check) NA NA private locks but not get into
Locks
the application.
Data and
Results
Make sure that user can
display data but not change
Use chrom
data.
View Data And data handling
Check in Interactive
Results - Chrom (Check) files and NA
Graphics, Std and Custom
applications if
Chrom Report applications,
installed.
PolyView, and Method
Builder (import method).
Use chrom Make sure that user can
Recalculate Data data handling display and change data but
And Save (Check) files and NA cannot do batch recalculation.
Results - Chrom applications if Check in Interactive Graphics
installed. and PolyView.
Use chrom
Perform Batch data handling Make sure user can do all
Recalc And Save (Check) files and NA recalculations.
Results - Chrom applications if Check in System Control.
installed.

Access Control and Audit Trail Software 23 03-914942-00:3

 Entry Range of Input Test Pass Function test Pass
Values Date Date
Name Name
Make sure that user can
Use MS data display data but not change
handling files data.
View Data And
(Check) and NA Check in MS Data Review,
Results - MS
applications if Std and Custom MS Report
installed. applications, Method Builder,
and MakeMS and BatchSMS.
Make sure that user can
display and change data but
Use MS data
cannot do batch recalculation.
Recalculate Data handling files
Check in MS Data Review
And Save (Check) and NA
normal processing and
Results - MS applications if
manual recalculations
installed.
screens, and MakeSMS and
BatchSMS.
Use MS data Make sure user can do all
Perform Batch handling files recalculations.
Recalc And Save (Check) and NA Check in System Control and
Results - MS applications if MS Data Review normal
installed. processing.
Methods
Use chrom Make sure that user can see
data handling a method but not modify it.
View Methods -
(Check) files and NA Check in Method Builder,
Chrom
applications if System Control, and
installed. Interactive Graphics.
Use chrom Make sure that user can
data handling change method and either
Modify Methods -
(Check) files and NA save it as the same name or
Chrom
applications if to a different name.
installed. Check in Method Builder.
Make sure that user can see
Use MS data a method but not modify it.
handling files Check in Method Builder,
View Methods -
(Check) and NA System Control, MS Data
MS
applications if Review manual recalculations
installed. screens, Active Compound
Set Editor.
Make sure that user can
Use MS data change method and either
handling files save it as the same name or
Modify Methods -
(Check) and NA to a different name.
MS
applications if Check in Method Builder and
installed. MS Data Review manual
recalculations screens.
In Method Builder, check that
the Delete Section function
offers the option to Delete the
Delete Methods (Check) NA NA whole method when all
sections are selected for
deletion, if and only if this
right is present.

Access Control and Audit Trail Software 24 03-914942-00:3

 Entry Range of Input Test Pass Function test Pass
Values Date Date
Name Name
Check that this Rights
MS Instrument Category is present only for
an MS Workstation
Check that Autotune can be
performed in MS drivers in
Autotune an MS (Check) NA NA
System Control if and only if
this right is present.
Check that Manual Tuning
functions can be performed in
MS Drivers in System Control
if and only if this right is
Manually Tune present.
(Check) NA NA
an MS Check that clicking on the
various elements of the MS in
the 1200 status window only
brings up tuning windows if
this right is present.
Check that the fields used to
execute macros are
Execute a accessible in the 1200
(Check) NA NA
1200MS Macro Control Window in System
Control if and only if this right
is enabled.
Check that the PML editor
Edit a 1200MS
(Check) NA NA can only be used to edit files
Macro
if this right is enabled.
Instrument
Make sure user can see
View Instrument
(Check) NA NA instrument status but not
Status
make a run.
Make sure user can run
Run Without
(Check) NA NA samples but not do “C” type
Standards
runs.
Run With Make sure user can do all
(Check) NA NA
Standards types of runs.
Make sure the ability to
reconfigure the instruments,
Change and
(including changing
Configure (Check) NA NA
instrument ID) is based on
Instruments
whether or not this right is
present.
Make sure rights have been
Add/Apply Rights Click NA NA
changed.
Make sure that all rights are
Remove Rights Click NA NA removed for the current user
for the current project.
Make sure this command
Clear All Click NA NA unchecks all the rights in the
table.
Make sure this command
Set All Click NA NA
checks all the rights in table.

Access Control and Audit Trail Software 25 03-914942-00:3

 Entry Range of Input Test Pass Function test Pass
Values Date Date
Name Name
For each user in the database
make sure the User Report is
printed and accurately
Print User Report Click NA NA
represents the rights given to
each user in the various
projects.
Make sure that the Users page entries are not discarded when the application is exited. Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 26 03-914942-00:3

 Groups Page Entries
Entry Range of Input test Pass Function test Pass
Values Date Date
Name Name
Group 1 to 15 Type in valid and Make sure all groups can
Name characters invalid names. be accessed.
Make sure all groups
All created
Groups in the list can be NA NA
groups
selected.
Make sure that
Group ID NA number is present for NA NA NA
each group.
Make sure all users
All created can be selected for as
User List NA NA
users many groups as
desired.
Make sure all Make sure that all
All created
Members members can be members of a group have
users
selected. the group rights.
Add Make sure selected
(Click) NA NA
Member user is added.
Remove Make sure selected
(Click) NA NA
Member user is removed.
Make sure that rights
Make sure that new
Create (Click) now apply to group
group is created.
members.
Make sure that list of Make sure that the added
Modify (Click) members of modified or removed users have
group is modified. the appropriate rights.
Make sure that users no
Make sure that the longer have rights
Remove (Click)
group is removed. associated with that
group.
Groups Page Rights Entries
Entry Range of Input Test Pass Function test Pass
Values Date Date
Name Name
Project Make sure all projects Make sure rights entered
Select Project
names can be accessed. stay with project.
System
Make sure user has
Workstation
(Check) NA NA appropriate rights in
Administrator
rights check software.
Perform Make sure user has
System (Check) NA NA appropriate rights in
Maintenance rights check software.
Unlock Private (Check) NA NA Make sure user has
Locks appropriate rights in
rights check software.

Access Control and Audit Trail Software 27 03-914942-00:3

 Entry Range of Input Test Pass Function test Pass
Values Date Date
Name Name

Data And
Results
Make sure user has
View Data And
(Check) NA NA appropriate rights in
Results
rights check software.
Recalc Data Make sure user has
And Save (Check) NA NA appropriate rights in
Results rights check software.
Perform Batch Make sure user has
Recalc And (Check) NA NA appropriate rights in
Save Results rights check software.
Methods
Make sure user has
View Methods (Check) NA NA appropriate rights in
rights check software.
Make sure user has
Modify Methods (Check) NA NA appropriate rights in
rights check software.
Make sure user has
Delete Methods (Check) NA NA appropriate rights in
rights check software.
Check that this Rights
MS Instruments Category is present only
for an MS Workstation
Make sure user has
Autotune an
(Check) NA NA appropriate rights in
MS
rights check software.
Make sure user has
Manually Tune
(Check) NA NA appropriate rights in
an MS
rights check software.
Make sure user has
Execute a 1200
(Check) NA NA appropriate rights in
Macro
rights check software.
Make sure user has
Edit a 1200
(Check) NA NA appropriate rights in
Macro
rights check software.
Instruments
Change And Make sure user has
Configure (Check) NA NA appropriate rights in
Instruments rights check software.
Make sure user has
Run Without
(Check) NA NA appropriate rights in
Standards
rights check software.
Make sure user has
Run With
(Check) NA NA appropriate rights in
Standards
rights check software.
Make sure no rights are
Clear All Click NA NA
displayed.

Access Control and Audit Trail Software 28 03-914942-00:3

 Entry Range of Input Test Pass Function test Pass
Values Date Date
Name Name
Make sure that all
Remove Rights Click NA NA checked rights are
removed.
Add/Apply Make sure rights have
Click Na NA
Rights been changed.

Make sure that the Groups page entries are not discarded when the application is exited. Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 29 03-914942-00:3

 Workstations Page Entries

Entry Range Input Test Pass Function test Pass

Date Date
Name Name
Use a
Check to see that
standalone Run the system from the
(Check) proper inputs become
system standalone database.
available.
workstation
Check to see that you
Browse Check to see that you
NA can use different security
Security File can see security files.
files.
Use A Check to see the
(This function is
Security (Check) proper entries are NA
evaluated later)
Server available.
Create valid and
Workstation 1 to 15
invalid workstation NA NA
Name characters
names.
Make sure all
Workstations NA NA NA workstations created are
listed here.
Make sure that all
Apply ID NA NA workstations have unique
IDs.
Make sure that you can
Create WS (Click) NA NA access the new
workstation.
Make sure that the
Modify WS (Click) NA NA workstation name and ID
have changed.
Make sure that the
Remove WS (Click) NA NA workstation has been
removed.

Make sure that the Workstations page entries are not discarded when the application is exited. Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 30 03-914942-00:3

 Instruments Page Entries

Entry Range Input Test Pass Function Test Pass

Date Name
Name Date
Make sure all instruments
Instruments NA NA NA
are listed.
Make sure that preset
names are created for
each workstation.
Make sure that the
Enter valid and invalid
Instrument 1 to 15 Instrument name is read
names.
Name characters on the appropriate
Make sure that same
instrument.
name cannot apply to
two different
instruments.
Make sure that the actual
Select any of the
Select from instrument is correctly
Workstation workstations that are
list identified at the
displayed.
workstation.
Make sure that two
Instrument instruments on the same
1 to 4 Select all four entries.
Number workstation cannot have
the same number.
Make sure that you can
Create Click NA NA
access new instrument.
Make sure that
Modify Click NA NA instrument number has
changed.
Make sure that the
Remove Click NA NA instrument is no longer
present.
Make sure that all of
the projects are
Projects NA displayed and can be
selected for an
instrument.
Make sure that rights
Projects
assigned to a project are
Allowed NA NA NA
applicable to that
Access
instrument.
Make sure project is
Add Project Click NA NA
added to the list.
Remove Make sure project is
Click NA NA
Project removed form the list.
Make sure that the Instruments page entries are not discarded when the application is exited. Pass
Make sure that single-instrument workstations are handled correctly. Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 31 03-914942-00:3

 Projects/Reasons Page Entries

Entry Range of Input test Pass Function test Pass

Values Date Date
Name Name
Make sure all projects
can be selected in the
Project 1 to 15 Input valid and invalid Projects lists on other
Name characters project names. pages: Users, Groups,
Instruments, and Rights
Checks.
Make sure all projects
Make sure that the
have different project
project ID is correct in all
Project ID NA numbers and that the
user/instrument
Global project has a
associations.
0.
Make sure this is the
directory that System
Any existing
Control defaults to for
Data directory 0 – (Checked in other
storing data. It should NA
Directory 511 applications)
be able to be changed
characters
at the user's
discretion.
Make sure that the button
Browse Click NA NA allows the detection of all
directories.
Make sure that new
Create Click NA NA
projects are added to list.
Make sure that new data
Modify Click NA NA directory is associated
with the new directory.
Make sure that the
project has been
removed from all
Remove Click NA NA user/instrument
associations, and
Projects lists on other
pages.
Check that all Check that all reasons
1 to 78
Reasons characters can be are displayed in
characters
entered. operation.

Make sure that the Projects page entries are not discarded when the application is exited. Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 32 03-914942-00:3

 Rights Checks Page Entries

Entry Range of Input test Pass Function test Pass

Values Date Date
Name Name
User / Once a user is selected,
Click to select Make sure all users
Project / a list of projects is
user from list are listed here.
Instrument displayed.
User / Click to select Make sure all projects Once a user is selected,
Project / project from the user is associated a list of instruments is NA
Instrument list with are displayed displayed.
Make sure all
User / Click to select Once an instrument is
instruments
Project / Instrument selected, a list of rights is NA
associated with the
Instrument from list displayed.
project are listed here.
Restarts the selection
Start Over Click NA NA process, displaying a list
of users.
Make sure
Enabled/Disabled Make sure Trace
Click on a state of each right is information is displayed
Rights Right to Trace correct for the current NA at the bottom of the
it. User / Project / window for the selected
Instrument right.
combination.

Make sure that the Rights page entries are not discarded when the application is exited. Pass

Make sure that the Rights for any individual are correct and can be printed. Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 33 03-914942-00:3

 Operational testing

Scope and Purpose

Operational testing will be done to make sure that newly added features of the system operate as they
are described in the product definition, the regulations, the test plan and the operator’s manual. It is the
job of the evaluator to make sure that the manual matches the actual operation.

Operational testing will be done on both Windows NT, 2000, and XP. The most recent versions of these
operating systems should be used. There are no requirements for the system to have instruments
attached to it during this testing.

Access Control and Audit Trail Software 34 03-914942-00:3

 Rights Tests
Scope and Purpose
The user input testing will check whether the administration security server can input the information
properly and display it. Operational testing will focus on making sure that the rights assigned to a user
apply to the user and that the user cannot get more rights than are assigned.
The following will be tested:
1. Check to see that whatever rights are assigned to a user, they control his access to the system.
2. Check to make sure that all actions requiring reasons will prompt the user for reasons and record
reasons accurately.
3. Check to make sure that the user cannot obtain more rights than they are entitled to.
4. The assignments of rights will be checked with the security server configured locally and with it
configured on the network.

The operation will be checked while someone is changing rights on the security server.

Rights Test Expected Pass

Result Date
Name
Method Builder
Without any method rights
Try to log into Method Builder Fail
Click on the method button on an instrument in System Control Fail
Double clock on a method through explorer Fail
Select a method from the tool bar Fail
Try other ways to get into the Method Builder Fail
Chrom Data Handling Only
Try to get into the Method Builder from Interactive Graphics Fail
MS Data Handling Only
Try to get into the Method Builder from MS Data Review normal Fail
processing screen
Try to get into the Method Builder from MS Data Review manual Fail
recalculations screens

With only the rights to view a method

Log into Method Builder and view any method and any version of a Pass
method
Try to change a method Fail
Chrom Data Handling Only
Try other approaches to change a method (Interactive Graphics, etc.) Fail
MS Data Handling Only
Try other approaches to change a method. (MS Data Review manual Fail
recalculations screens, etc.)

With the right to modify a method

Create new versions of a method Pass
Create 20 internal versions of a method and make sure that you can Pass
access any of them
Create 20 internal versions of a method and make sure that you can run Pass
any of them
Modify a method and save it as another name Pass
Import a method from a data file and save it Pass

Access Control and Audit Trail Software 35 03-914942-00:3

 Modify a method and try to save it as a method that already exists Fail
Modify a method that is password protected and try to save it. (without the Fail
password)
Modify a method that is password protected and try to save it as a different Pass
name
Modify a method that is password protected and save it as the same using Pass
the password

With the right to Delete a Method

In Method Builder, if you request to delete all sections of a method, you Pass
are offered the option delete the file
No -> File is not deleted Pass
Yes -> File is deleted Pass

Without the right to Delete a Method

The above option is not available when deleting all sections of a method.

MS Data Handling Only

Import a Compound list and save the method Pass
Select a data file to view, calculate Target Ion Ratios from it, and perform Pass
local Target Compound integrations
Modify a method in MS Data Review manual recalculations and save it Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 36 03-914942-00:3

Perform the following tests on data files for chromatography data handling:

Rights Test Expected Pass

Result Date
Name
Interactive Graphics
Without any data and results rights
Try to log into Interactive Graphics Fail
Double click on a .RUN file through explorer Fail
Select a .RUN file from the Star tool bar Fail
Try other ways to get into the Interactive Graphics Fail
Try to access Report Fail
Try to open a custom report, PolyView, Star Finder and Aurora Fail

With the right to view data only

Log into Reports and display data – also print the report Pass
Log into Interactive Graphics and display a chromatogram (several of Pass
them)
Log into Interactive Graphics and try to recalculate and save a Fail
chromatogram
Log into custom report writer and view a custom report Pass
Log into batch reprocessing and try to recalculate a group of .RUN files Fail
Log into System Control and try to recalculate data through a sequence Fail

With the rights to recalculate and save results but not to do batch
reprocessing
Log into Interactive Graphics and try to recalculate results Pass
Log into Interactive Graphics, display several chromatograms and try to Pass
recalculate all of them
Log into Report and Custom Report writer and view a chromatogram. Pass
Log into PolyView, Aurora, and Star Finder Pass
Log into batch printing and try to recalculate a group of .RUN files Fail
Log into System Control and try to recalculate data through a sequence Fail

With the rights to batch recalculate data.

Log into Interactive Graphics, Report and Custom report write and do Pass
everything
Log into Batch reprocessing and reprocess a group of files Pass
Log into System Control and batch recalculate data Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 37 03-914942-00:3

Perform the following tests on data files for MS data handling:

Rights Test Expected Pass

Result Date
Name
MS Data Review and related applications
Without any data and results rights
Try to log into MS Data Review Fail
Double click on a .SMS file through explorer Fail
Select a .SMS file from the Star tool bar Fail
Try other ways to get into the MS Data Review Fail
Try to access Standard MS Report Fail
Try to open a Custom MS Report Fail
Log into Method Builder, and try to select and view a chromatogram, Fail
calculate Target Ion Ratios, and integrate Target Compounds
Log into Method Builder, and import a data file method Pass

With the right to view data only

Log into MS Data Review and display a chromatogram (several of them) Pass
Log into MS Data Review and recalculate and save the active Fail
chromatogram.
Log into MS Data Review, do manual recalcs, and try to save them Fail
Log into MS Data Review and try to reprocess a recalc list Fail
Log into System Control and try to recalculate data through a sequence Fail
Log into Std MS Reports and display data – also print the report Pass
Log into Custom MS Reports and view a custom report Pass
Log into batch printing and print a group of .SMS files Pass
Log into Method Builder, and select and view a chromatogram, calculate Pass
Target Ion Ratios, and integrate Target Compounds

With the rights to recalculate and save results but not to do batch
reprocessing
Log into MS Data Review and try to recalculate and save the active Pass
chromatogram
Log into MS Data Review, do manual recalculations, and save them Pass
Log into MS Data Review and try to reprocess a recalc list Fail
Log into System Control and try to recalculate data through a sequence Fail
Log into Std and Custom MS Reports and do everything Pass

With the rights to batch recalculate data.

Log into MS Data Review, Std MS Reports and Custom MS Reports, Pass
and do everything.
Log into System Control and batch recalculate data. Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 38 03-914942-00:3

 Rights Test Expected Pass Date
Result Name
System Control
Without any System Control rights
Try to log into System Control Fail
Try to change from the System Control configuration screen that has Fail
been locked to one of the instruments.
Try to change from an instrument screen that has been private locked to Fail
another instrument

With the right to view instrument status

Log into System Control and try to view instruments Pass
Log into System Control and try to change instrument configuration Fail
Log into System Control and try to run the instrument Fail

With the right to run samples without standards

Log on and run a single sample (Run all run types except a C type) Pass
Log on and run a sample list with all run types except a C type Pass
Log on and run a sequence with several different sample lists with all run Pass
types except a C type
Log on and try to run a single sample with a C type Fail
Log on and try to run a sample list with one or more samples – not the Fail
first sample- as a C type Should run but not run as a C type
Log on and try to run a sample list with all non-C type samples and then Fail
suspend automation and add C type runs to the sample list
C type should be converted to A type
Log on and try to run a sequence with the first sample list having C type Fail
samples. Should run but not run a C type run
Log on and try to run a sequence with one of the sample lists having a C Fail
type run Should run but convert C to A
Log on and run a sequence, suspend automation and add a sample list Fail
that has a C type run Should convert C to A type.

With the right to run samples with standards

Log on and run a single injection with a C type run Pass
Log on and run a sample list with a C type runs Pass
Log on and run a sequence with one or more sample lists having C type Pass
runs

With the right to change instrument configuration and ID.

With the right to change instrument configuration and ID, try to change Pass
the instrument configurations
Without the right to change instrument configuration and ID, try to Fail
change them

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 39 03-914942-00:3

 Rights Test Expected Pass
Result Date
Name
System rights
Without system administrator rights
Try to log on to the system administration program Fail

With system administrator rights

Run system administration Pass

With rights to unlock private lock

Try to unlock private lock when you have the right to the application Pass
Try to unlock private lock when you do not have the right to the Pass
application

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 40 03-914942-00:3

Perform the following tests on MS Workstation Only

Rights Test Expected Pass

Result Date
Name
MS Instrument (Check in System Control)
Without the right to autotune an MS
Try to perform Autotune for the 2000 MS Fail
Try to perform Autotune for the 1200 MS Fail

With the right to autotune an MS

Try to perform Autotune for the 2000 MS Pass
Try to perform Autotune for the 1200 MS Pass

Without the right to manually Tune an MS

Try to change the trap multiplier offset for the 2000 MS Fail
Click on the picture of the Detector in the 1200 MS Status Display Nothing

With the right to manually tune an MS

Try to change the trap multiplier offset for the 2000 MS Pass
Click on the picture of the Detector in the 1200 MS Status Display, then Pass
change the detector voltage

Right to execute 1200 Macros

Without this right, try to enter the macro command ?2+2 in the ‘Ctrl’ field Fail
at the bottom of the 1200 control window. Repeat for the ‘Proc’ field.
Repeat with this right enabled. The ‘Out’ field should display 4

Without the right to edit 1200 Macros

Execute Tools->PML Editor command from the 1200 Control Window. Pass
Open a PML, try to modify it Fail

With the right to edit 1200 Macros

Modify and save a PML Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 41 03-914942-00:3

 Administration Security Audit Log
Scope and Purpose

The administration security audit log records all of the actions that an administrator makes using the
administration security server software. It also records any alerts such as the repeated failure of a login or
the powering down of the PC where the security database is located. These tests will check the following:

1. Check to see that all entries and modifications made to the security database are correctly
logged.
2. Check to see that alarm conditions are properly logged and that an administrator is informed
when an alarm occurs.
3. Check to see that the information in the security server can be printed out correctly.
4. Check to see that the log can be archived and that a new log is automatically created in the
correct manner.

Run this test on the security server both on the network and on the local PC

Administration Security Audit Log Tests Expected Pass

Result Date
Name
Log accuracy
Enter a variety of actions in the administration security software, Pass
carefully recording (on paper) what you have done
Make sure that the log accurately reflects what was done
( Attach printout of log and written or typed list)
Open a second session and repeat the process Pass
Make sure that the new entries are correct.

Alarm conditions
Create alarm conditions and make sure that they are accurately Pass
recorded in the log
Make sure that the alarms can be cleared from the log maintenance Pass
screen

Printing the log

Print the log and make sure that the printout is correct Pass

Archiving the log

Archive the security audit log. Make sure the old log can be read back Pass
and that it has the proper starting and ending entries
(See Operation manual for these.)
After archiving, open the newly created log and make sure that the first Pass
entries are correct

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 42 03-914942-00:3

Accessing the Security Server from Multiple Workstations

Scope and Propose

When the security server is located on a network, it can be accessed from a variety of workstations.
Access from these individual workstations is necessary to configure each workstation in the security
server database. Also, administrators can log on from anywhere in the system both for the purpose of
modifying the security server database and operating the workstations. This section tests this multi-
workstation operation. The evaluation will test network security database operation for the following:
1. Check to see that multiple workstations can be configured on a network server.

2. Check to see that administrators can access the security database from different workstations.

3. Check to see that administrators can work on the same database at the same time safely.

4. Check to see that alarms will be displayed to any administrator who logs onto the network no
matter where the alert was generated.

Accessing the Security Database From Multiple Workstations Expected Pass

Result Date
Name
Configuring multiple PCs
Configure 5 different PCs on a network and make sure that they keep Pass
their proper identity
The PCs should be a mixture of MS workstations and Star single- and
multiple- instrument workstations
Run some operations on each to make sure that the rights assigned to a Pass
project can properly conveyed to each PC

Accessing the security data base

Log on as an administrator from each of the 5 PCs and make changes to
Pass
the security database
Check from another PC that they are correct.
Log on as an administrator while someone else is already logged on as Pass
an administrator
Try to make changes in the security database.

Accessing alarms from different PCs.

Create an alarm on one workstation, log in to another workstation as an Pass
administrator (in a regular application) and make sure that you are
informed about the alarm
Create an alarm on one workstation while an administrator is already Pass
logged on and see if they are informed of the alarm

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 43 03-914942-00:3

 System Log and Message Logs
Scope and Purpose
When the system is running, all significant actions on a workstation in the system are logged in two
places, the system log and the message log. A message log is associated with each instrument in
System Control. When samples are run either individually or as part of automation, a message log is
created. This message log ( which is present in all of the workstation software versions) contains all of the
information about what was done to the samples ( methods used, instrument errors etc.). In earlier
workstation versions, the message log was overwritten as soon as a new run or sequence of runs was
begun. Now, the message log will be permanent. In addition, the message log is coupled with the system
log.

The system log is a log that reflects what was done on the entire workstation. This includes things like
who logged into which application and when, what they did in that application and when they logged out.
A system log is automatically generated on each workstation when the Access Control and Tracking
Software is first started. It is continually maintained with no intervention from the user. Message logs are
referenced and stored with the system log. After either the size of the system log or the number of days
that the system log is active exceeds the limits, it is automatically archived and a new one is created. The
last entry in the old system log and the first entry in the new system log will refer to each other, thus
maintaining the continuity of the audit. During the evaluation, the following will be tested:
1. Check that the appropriate entries are put into the system log.
2. Check that the appropriate message logs are referenced in the system log.
3. Check that the message log cannot be overwritten.
4. Check that the system log can be archived and a new one started in an appropriate fashion.
5. Check that the system log can be displayed correctly.
System and Message Log Test Expected Pass
Result Date
Name
Saving information in the system log
After doing a detailed set of operations, make sure that the system log Pass
reflects all of these actions
After running 2 or more automation sequences using different login identities, Pass
and some manual operations using a third login identity, make sure that all
activities are stored in the message log correctly
Make sure that the correct message logs are referenced in the system log Pass
Preserving the message log
Make sure that the message logs are not over written when a new automation Pass
is started
Make sure that a new message log is started when a new automation is Pass
started
Displaying and archiving the system log
Make sure that the active system log can be displayed Pass
Make sure that the message log can be accessed from the system log and Pass
from the log viewer
Make sure that when the system log is automatically archived, a new one is Pass
created and the appropriate messages put as the last entry of the old and the
first entry of the new one
Make sure that an archived system log can be displayed and searched Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 44 03-914942-00:3

 Method Editing
Scope and purpose

The ability to have internal versions of a method has been added to the workstation software. These
internal versions allow changes to be made to a method without completely obscuring the original
method. The evaluation will test the accuracy and readability of the versioning system by doing the
following:

1. Check to see that changes to a method are kept in the newest version of the method.

2. Check to see the older versions of the method can be accessed and run.

3. Check to make sure that the compare software automatically highlights the method changes.

4. Check to make sure that a method can be saved to a new name and have the correct version
saved with no other versions present.

5. Check to make sure that the password protection for a method functions correctly.

Method Versioning Test Expected Pass

Result Date
Name
Internal method versioning
Build a method and then modify it 10 times. Make sure that all of the Pass
versions are correct
Run an older version of a method Pass
When running an older version of a method, check to see that the proper Pass
entries are made in the run log
Check to see that when a method is saved to another name, only the Pass
current version is saved
Try to save a method with the name of a method that already exists Fail
Try to save a method that is password protected with a different name Pass
Try to save a method that is password protected as the same name when Pass
you have the password
Make sure that a request for reasons is always asked for when modifying Pass
a method and that you must enter a reason or you cannot save the
changes
Make sure you can exit Method Builder without saving changes and that Pass
the method is not changed

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 45 03-914942-00:3

 Data File Versioning

Scope and purpose

Recalculation of results can be done in several different ways. When results are recalculated, the
previous results must be available for review and print, and a reason for the new results calculation must
be present. During the evaluation, the following will be checked:

1. Check to see that the changes to the data file are properly recorded.

2. Check to see that the previous version is still readable.

3. Check to see that the software can save a large number of versions.

4. Check to see that you cannot save results without giving a reason for making the changes.

5. Check to see that you can abandon making changes without any changes being made.

Chromatography Data Handling

Result File Versioning Test Expected Pass

Result Date
Name
Interactive graphics
Make 10 recalculations and make sure that the changes are properly made Pass
in the data file
Make sure the previous 9 versions can be read and printed Pass
Make sure that you must enter a reason for a change Pass
Make sure that you can abandon changes and they are not stored in the Pass
data file
Display 7 files in Interactive Graphics, recalculate all and make sure that Pass
the reason entered is stored in all of the files
Standard reports
Make sure the previous versions can be read and printed Pass
Batch reprocessing
Batch reprocess 10 data files and make sure that they all are changed Pass
correctly
Make sure that the same reason is put into all of the data files Pass
System control
Batch reprocess 10 data files and make sure that they all are changed Pass
correctly
Make sure that the same reason is put in all of the data files Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 46 03-914942-00:3

MS Data Handling

Result File Versioning Test Expected Pass

Result Date
Name
MS Data Review – normal processing, active data file
Make 10 recalculations of the active data file and make sure that the Pass
changes are properly made in the data file
Make sure the previous 9 versions can be read and printed Pass
Make sure that you must enter a reason for a change Pass
MS Data Review – normal processing, recalc list
Reprocess a recalc list that contains 10 data files and make sure that they Pass
all are changed correctly
Make sure that the same reason is put into all of the data files Pass
System control
Batch reprocess 10 data files and make sure that they all are changed Pass
correctly
Make sure that the same reason is put in all of the data files Pass
MS Data Review – manual recalculations
Make 10 recalculations of the active data file and make sure that the Pass
changes are properly made in the data file
1 recalculation is defined as leaving the manual recalculations screens after
1 or more manual recalculations have been performed
Make sure the previous 9 versions can be read and printed Pass
Make sure that you must enter a reason for a change Pass
While doing manual recalculations, make sure that combinations of the Pass
following actions are done:
a) In the Target Compound screen, re-integrate some compounds
after dragging peak events, some after editing the method, and
leave some untouched
b) In the Unknown Peaks screen, do successive re-integrations after
dragging peak events and editing the method
When changes are saved upon exiting the manual recalculations screens,
make sure that only the last re-integrations done on each peak are saved
Make sure that you can abandon changes when leaving the manual Pass
recalculations screens and they are not stored in the data file
Standard MS reports
Make sure the previous versions can be read and printed regardless of how Pass
they were generated

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 47 03-914942-00:3

 1200 Macro Versioning

Scope and purpose

The Macros specific to the 1200 instrument now contain an audit trail like the data files and methods.
During the evaluation, the following will be checked:

1. Check to see that the changes to the PML file are properly recorded.

2. Check to see that the previous version is still readable.

3. Check to see that the software can save a large number of versions.

4. Check to see that you cannot save results without giving a reason for making the changes.

5. Check to see that you can abandon making changes without any changes being made.
PML Versioning Test Expected Pass
Result Date
To be done from an account with the right to modify PMLs Name
Open the Editor from Tools->PML Editor… in the 1200 Control Window Pass
Create a New PML containing “Line1”;cr; and save it with rev info Pass
Add lines “Line2”;cr; through “Line10”;cr; saving it each time with Pass
revision info
Print the PML and verify that its contents are correct Pass
Print the PML Version Info and verify that the revisions are properly Pass
documented
Exercise the Open Version command and check that you can retrieve an Pass
older version of the PML
Check that you are prompted to save changes if you attempt to exit Pass
without changes
Check that electing to not save changes preserves the currently saved Pass
file.

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 48 03-914942-00:3

System Control

Scope and Purpose

The Rights check part of the test plan (above) tests most of the individual and group rights. However,
System Control has a number of specific interactions that should be specifically tested. This part of the
evaluation will test the following:

1. Check to make sure that rights are apportioned to each instrument correctly when multiple
instruments are being run at the same time.

2. Check to make sure that changes made to an instrument’s run parameters in System Control are
NOT entered into the method.

3. Check to make sure that a user cannot significantly alter the operation of an instrument.

Detailed System Control Rights Interaction Test Expected Pass

Result Date
Name
Multi Instrument operation
Log onto one instrument, perform some operations for which you have Fail
the rights, then go to another instruments and perform some operations
for which you do not have the rights

Mixed use operation

Create a sequence on one instrument that contains injections and Fail
recalculations when you do not have the rights to recalculate data.
Should skip the recalc when it gets to that point
In MS workstations, invoke the MakeMS and Activate (compound table Pass
set) utilities as Autolink entries in the sample/recalc lists
Also specify the following Sample Types in the lists: Print Calib after a
calibration block, and Print Summary at the end

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 49 03-914942-00:3

 Private and Public Locks
Scope and Purpose

The Varian workstations can accommodate several different operations on one workstation at the same
time. Although only 1 person at a time can be logged into a workstation, they can start automated actions
and then log out. This allows another individual to log in and perform tasks while the original tasks are
continuing. When one person is logged in and they have started a process, they can make sure that no
one else can interact with that operation. This is called a private lock. When an operation is private
locked, only the person who has locked it and someone authorized to open private locks can open it.
When a private lock is opened it becomes a public lock. A public lock can be opened by anyone with the
rights to that application. Also, when someone leaves the workstation unattended, the system will
automatically public lock. During the evaluation, the following will be checked:
1. Check to see that a public lock is created when an application times out.
2. Check to see that a private lock can be created by the user.
3. Check to see that the private lock status monitor correctly reflects that locked state.
4. Check to see whether a private lock can be opened only by someone who has the right to open
private locks.
5. Check to see that someone who can open a private lock cannot access the applications unless
they have the rights to use that application.
Private Lock Test Expected Pass
Result Date
Name
Creating a private lock
Make sure that a user can private lock the system using the lower tool Pass
bar icon
In multi-instrument workstations, make sure that each of the instruments Pass
in System Control can be private locked and unlocked independently
Make sure that if a user tries to log into another application, the system Pass
acts like a public lock (must have a login).

Timeouts
Make sure that all applications create a public lock when they time out Pass
Make sure that anyone can open the public lock (if they have rights on Pass
that application) that was created by a timeout

Opening a private lock

Make sure that the logged in user can open their own private lock Pass
Make sure that someone with the right to open private locks can open a Pass
private lock but must log in to the application to access it

Display of lock information

Make sure that the lower tool bar icon displays the correct information Pass
about the locks
Make sure that creating and opening private locks are recorded in the Pass
security audit log
Make sure that a lock is displayed in each part of System Control when it Pass
is locked

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 50 03-914942-00:3

 Electronic Signatures
Electronic Signatures Test Expected Pass
Result Date
Name
With Adobe Acrobat installed

Make sure that all print commands can print to distiller Pass

Make sure that automated print commands can print to distiller Pass

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 51 03-914942-00:3

 Required Reasons

Scope and Purpose

Whenever a change is made to a data file, method file, administration file or for many other activities, the
change requires a prompt for a reason.

Required Reasons Test Expected Pass

Result Date
Name
Completeness
Make sure that all actions that change a method or a data file prompt the Pass
user for a reason
Make sure that all actions that change the security database prompt the Pass
user for a reason

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 52 03-914942-00:3

 Other Workstation Applications
Scope and Purpose

Chromatography Data Handling

Chromatography Workstation applications such as PolyView, Aurora, Star Report Writer and Star Finder
are all controlled by Access Control and Audit Trail software. These applications deal with .RUN files. You
need the rights to view data to access them. Whatever file structure (reduced file data with or without raw
data) you have created as part a method is not checked, because the method will identify what was done.
If you are running 21 CFR 11 software, the ability to manually delete the raw data while keeping only the
channel data will be eliminated. Either the raw data will stay in the file or it will go to a backup file. The
evaluation will check the following:

1. Check access to other applications using the appropriate rights.

2. Check operation of PolyView using appropriate rights including being logged into the project
through which the data was generated.

3. Make sure that the raw data is always saved at least in a backup file.

Note: there are no limitations on the access to Aurora because results cannot be viewed or modified
through Aurora.

PolyView Test Expected Pass

Result Date
Name
PolyView access and operation
Make sure that you can access PolyView only if you can view data Fail
Make sure that you can calculate results only if you have the right to Fail
modify results
Make sure that if you log on using the global project and you have right to Pass
modify data, you can recalculate any file

Saving raw data

Make sure that when you create channel data from PolyView, you must Pass
save the raw data either in the file itself or as a backup

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 53 03-914942-00:3

MS Data Handling
The following MS workstation applications that deal with .SMS files are all controlled by the Access
Control and Audit Trail software. The MS Custom Reports applications that can be optionally installed
generate reports from the results that are stored in the data files. They customize the content and format
of the reports as appropriate for the target markets, but they do not modify or regenerate the stored
results. The MakeMS, MakeSMS, and BatchSMS convert data files between the current .SMS format and
the previous .MS format, which is not supported by the AC&AT software. The Active Compound Set
Editor and Activate applications maintain and invoke sets that specify which compounds in the method
Compound Table are active, i.e., will be processed when the method is executed. The evaluation will
check the following:
1. Check access to the applications using the appropriate rights.
2. Check operation of the applications using appropriate rights, including being logged into the
project through which the data was generated.
Note: There are no limits to invoking these applications in System Control. This is covered by the ability
to access System Control and run Samples or do Batch Reprocessing.
Other MS Applications Tests Expected Pass Date
Result Name
Custom MS Reports access and operation
Make sure that you can access these applications from the workstation Fail
applications Toolbar only if you can View Data
Make sure that you can perform any operations in these applications Pass
once they are accessed

MakeMS access and operation

Make sure that you can access it from the command line and convert 1 or Fail
more .SMS files to .MS only if you can View Data
Make sure that you can invoke it in System Control as an Autolink entry in Pass
the sample/recalc list

MakeSMS access and operation

Make sure that you can access it from the command line and convert 1 or Fail
more .MS files to .SMS only if you can Recalc Data

BatchSMS access and operation

Make sure that you can access it from the workstation applications Fail
Toolbar only if you can Recalc Data
Make sure that you can convert one or more files between .MS and .SMS Pass
once BatchSMS is accessed

Active Compound Set Editor access and operation

Make sure that you can access it from the workstation applications Fail
Toolbar and open one or more methods only if you can View Methods
Make sure that you can perform any operations (create, modify, and Pass
delete active compound sets for the method, and apply the current
settings to the method) once the active set editor has been accessed
Activate access and operation
Make sure that you can invoke it in System Control as an Autolink entry in Pass
the sample/recalc list.

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 54 03-914942-00:3

 Reliability Testing
Scope and purpose
Reliability testing is done to make sure that the system will run for a long period of time in a fully loaded
configuration. The system is tested with many different types of instruments attached. It is tested with
different software operating systems. The system will be run in automation with interactions with the
system on a periodic basis. The system should not fail for at least 3 days of fully loaded operation for it to
pass.

Configuration to run
Four instruments with AutoSamplers attached to the system. Periodic interactions with the system
through running recalculation in Interactive Graphics, using Adobe Acrobat to sign files, building new
methods and modifying old methods, printing reports, starting a stopping automation, and running the
security server.

Operating systems
Windows NT, 2000, XP. Use the most recent versions of these operating systems.

Evaluator ___________________ Date___________________

Software version_______________

Access Control and Audit Trail Software 55 03-914942-00:3

Appendix 2 – Suggested on Site Validation Procedures for
Varian Access Control and Audit Trail Software
The most important aspects of the Varian Access Control and Audit Trail software are its ability to
limit access to workstation applications based on the rights given to a user, and its ability to produce
accurate audit trails and versions of data files and method files. The table below lists the functions
that should be tested and the parts of the test plan listed in Appendix 1 that could be used as a
template for on-site validation. The Comments column suggests ways to limit the testing of each
function. Note: You must have administrator privileges on this system to perform these tests.

Function to test Section of test plan to use Comments

Does the assignment of rights Use only one way to access an
to an individual correctly limit application.
Rights tests
their access to the software Do not try all different ways to
functionality access an application.
Does the software that creates Check all
versions of methods work Method editing
correctly
Check all, for the data file types
Does the software which that are supported by the
creates versions of data files data file versioning workstations on the system.
work correctly

As an administrator, after
configuring the system for the
first time, check the Security
Security Audit Log Functions
Audit Log to make sure that the
entries you made are reflected in
the log
After performing the tests on
methods and data files, check
System Log Functions the System Log to make sure
that the entries appropriate to
your testing were entered

Access Control and Audit Trail Software 56 03-914942-00:3

Appendix 3 – Comparison of Varian workstations with Access
Control and Audit Trail (AC&AT) software to 21 CFR 11
regulations

Section Regulation Varian workstation functions

11.1 (a) The regulations in this part set forth the NA
criteria under which the agency considers
electronic records, electronic signatures, and
handwritten signatures executed to electronic
records to be trustworthy, reliable, and
generally equivalent to paper records and
handwritten signatures executed on paper.
11.1 (b) This part applies to records in electronic form All records created by the workstation are subject
that are created, modified, maintained, to the security system and the audit trail system.
archived, retrieved, or transmitted, under any Some of them such as the .RUN and .SMS (data)
records requirements set forth in agency and .MTH (method) files have their own audit
regulations. This part also applies to trails built in. Others, such as .SMP (sample lists)
electronic records submitted to the agency and .SEQ (sequences) are documented in the
under requirements of the Federal Food, external security audit log and workstation system
Drug and Cosmetic Act and the Public health log files.
Service act, even if such records are not
specifically identified in agency regulations.
However, this part does not apply to paper
records that are, or have been, transmitted by
electronic means.
11.1 (c) Where electronic signatures and their Electronic signatures generated in 3rd-party
associated electronic records meet the software such as Adobe Acrobat can be used to
requirements of this part, the agency will generate signatures.
consider the electronic signatures to be
equivalent to full handwritten signatures,
initials, and other general signings as
required by agency regulations, unless
specifically excepted by regulation(s)
effective on or after August 10, 1997.
11.1 (d) Electronic records that meet the requirements NA
of this part may be used in lieu of paper
records, in accordance with sec 11.2, unless
paper records are specifically required.
11.1 (e) Computer systems (including hardware and Documentation on operation, validation and
software), controls, and attendant compliance is available with every workstation
documentation maintained under this part software package. In addition, details of the
shall be readily available for, and subject to, development of this software may be reviewed at
FDA inspection. CSB.
11.2 (a) For records required to be maintained but not All files and records in the Varian system can be
submitted to the agency, persons may use maintained in a secure manner. They can have
electronic records in lieu of paper records or electronic signatures attached to them where
electronic signatures in lieu of traditional appropriate through software such as Adobe
signatures, in whole or in part, provided that Acrobat. There will always be a complete record
the requirements of this part are met. of who used or generated these files and when
they were generated and used.

Access Control and Audit Trail Software 57 03-914942-00:3

 Section Regulation Varian workstation functions
11.2 (b) For records submitted to the agency, persons NA
may use electronic records in lieu of paper
records or electronic signatures in lieu of
traditional signatures, in whole or in part
provided that: 1. The requirements of this part
are met; and 2. The document or parts of a
document to be submitted have been
identified in public docket etc.
11.3(a) The definitions and interpretations of terms NA
contained in section 201 of the act apply to
those terms when used in this part.
11.3(b) The following definitions of terms also apply NA
to this part.
11.3(b1) The Act means the Federal Food, Drug, and NA
Cosmetic Act (secs 201-903 (21 U. S .C. 321-
393))
11.3(b2) The Agency means the Food and Drug NA
Administration
11.3(b3) Biometric means a method of verifying an The AC&AT software does not support Biometric
individual’s identity based on measurement of identification at this time.
the individual’s physical features (s) or
repeatable actions (s) where those features
and/or actions are both unique to the
individual and measurable.
11.3(b4) Closed system means an environment in In most laboratories, the AC&AT system will be
which system access is controlled by persons considered a closed system.
who are responsible for the content of
electronic records that are on the system.
11.3(b5) Digital signature means an electronic The workstations uses Adobe Acrobat for digital
signature based upon cryptographic methods signatures.
of originator authentication, computed by
using a set of rules and a set of parameters
such that the identity of the signer and the
integrity of the data can be verified.
11.3(b6) Electronic record means any combination of Everything in the AC&AT system that is created
test, graphics, data audio, pictorial or other as a permanent record by the workstation
information representation in digital form, software is covered by the security, user
which is created, modified, maintained, identification, and audit trail features.
archived, retrieved or distributed by a
computer system.
11.3(b7) Electronic signature means a computer data Adobe Acrobat meets all requirements for
compilation of any symbol or series of electronic signatures.
symbols executed, adopted, or authorized by
an individual to be the legally binding
equivalent of the individual’s handwritten
signature.
11.3(b8) Handwritten signature means the scripted NA
name or legal mark of an individual and
executed or adopted with the present
intention to authenticate writing in a
permanent form.
The act of signing with a writing or marking
instrument such as a pen or stylus is

Access Control and Audit Trail Software 58 03-914942-00:3

 Section Regulation Varian workstation functions
preserved. The scripted name or legal mark,
while conventionally applied to paper, may
also be applied to other devices that capture
the name or mark.
11.3(b9) Open system means an environment in which The AC&AT system will usually not be considered
system access is not controlled by persons an open system. This, however, will be dependent
who are responsible for the content of on the individual company organization.
electronic records that are on the system. Compliance with open system requirements will
be SOP issues.
11.10 Controls for closed systems. Persons who NA
use closed systems to create, modify,
maintain, or transmit electronic records shall
employ procedures and controls designed to
ensure the authenticity, integrity and, when
appropriate, the confidentiality of electronic
records, and to ensure that the signer cannot
readily repudiate the signed record as not
genuine. Such procedures and controls shall
include the following:
11.10(a) Validation of systems to ensure accuracy, Results of testing at Varian as well as test
reliability, consistent intended performance, procedures to challenge the system are provided
and the ability to discern invalid or altered as part of the standard package. Each of the
records. security and audit trail features of the system can
be tested at the customer’s site.
Any file that has been changed either has an
internal audit trail that can be reviewed for who
has changed it and what the change was, or it will
be part of an external audit trail.
The individual who changed the file and the date
of the change is clearly identified. This can be
correlated with the security audit log to establish
that the individual had authority to make the
change.
The system will not allow any individuals to make
changes who have not been authorized to make
those kinds of changes.
The ability to generate accurate and complete All permanent Varian system files can be read on
copies of records in both human readable the display and printed on paper through the
and electronic form suitable for inspection, software itself. They can also be converted into
review and copying by the agency. Persons standard formats such as Adobe Acrobat format
should contact the agency if there are any for reading and printing by universally available
questions regarding the ability of the agency software.
to perform such review and copying of the
electronic records. All audit trails can be viewed and printed.
When there is an internal audit trail, each version
of the file can be printed individually.
11.10(c) Protection of records to enable their accurate Methods and data files that were created by all
and ready retrieval throughout the records earlier versions of Star WS software since its
retention period. introduction in 1988 can be converted to the
current file formats. Similarly, methods and data
files that were created by all previous Windows-
based versions of MS WS software since its
introduction in 1998 can be converted to the
current file formats. Previously generated results
are not compatible with the current data file

Access Control and Audit Trail Software 59 03-914942-00:3

 Section Regulation Varian workstation functions
format, and are deleted. Data files that were
created by the earlier DOS-based MS software
also can be converted to the current format with
conversion utility programs that are part of the MS
workstation software.
The file format conversions happen automatically
when the file is opened. The Access Control and
Audit Trail software will add protection and will
create and maintain an audit trail on the new files.
It will also note that the older versions of the files
were not created under a protected system.
Use of Window NT, 2000, or XP operating
systems will limit who is able to move and delete
files through the operating system itself.
11.10(d) Limiting system access to authorized The operating system must be Windows NT,
individuals. 2000, or XP to assure that access to the files
through Explorer is controlled.
The AC&AT software has a secure login and
password system that allows the assignment of
selected rights to create, maintain and change
files. In addition, these rights can be assigned on
a per project/per instrument basis.
By using the security server on a network,
individual rights to access instruments can apply
to all instruments and workstations.
11.10(e) Use of secure computer generated time Data files (.RUN or .SMS) have a built-in audit trail
stamped audit trails to independently record which record the person making the change, the
the date and time of operator entries and date the change was made, and the nature of the
actions that create, modify or delete change. The old results and the newly calculated
electronic records. Record changes shall not results are both stored in the data file as two
obscure previously recorded information. different versions. An unlimited number of
Such audit trail documentation shall be versions can be created if multiple recalculations
retained for a period at least as long as that are done. The user is prompted to enter a free
required for the subject electronic records form reason for the change. Company SOP
and shall be available for agency review and determines the type of entry that is acceptable for
copying. a reason for the change. The data is accessible
for as long as the files are accessible.
In a similar manner, a method file (so long as it
keeps the same name) has a built-in audit trail.
A Message Log is created whenever data files are
created through the System Control application.
This message log records all relevant information
about how the data was created, when it was
created, and who created it. This log is
permanently stored in the archive directory and
referenced in the system log.
A System Log and a Security Audit Log are
continuously created. These record what has
happened on the system or in the security
database, who performed the actions and when
they were done. These are permanent files that
are continuously maintained. When they are
archived, a new log is immediately created.

Access Control and Audit Trail Software 60 03-914942-00:3

 Section Regulation Varian workstation functions
11.10(f) Use of operational system checks to enforce Whenever there is a requirement that a sequential
permitted sequencing of steps and events, as set of steps occur, the workstation software
appropriate. performs those steps automatically in the proper
sequence.
11.10(g) Use of authority checks to ensure that only Rights are assigned to individuals and groups.
authorized individuals can use the system, These rights can be based on projects or they can
electronically sign a record, access the be global. They can be specific to instruments.
operation or computer system input and The ability to private and public lock the system is
output device, alter a record or perform the present. In this way, an individual can lock the
operation at hand. system and prevent anyone else from intervening
in the actions that he/she is performing.
A timeout is present for all actions. If no active
input from the user has been received for a period
of time set in the application timeout entry, the
system will automatically public lock to prevent
any unauthorized usage.
Each creation of a user on the system
automatically generates a unique random
representation associated with that user. This
representation cannot be duplicated even if the
same user with all of the same information is
created a second time or on a different
instrument. When a request for authentication of
the user is needed, this representation is used as
one of the bases for assessment.
The administration function produces an audit trail
so that each creation of a system user is
completely documented.
11.10(h) Use of a device (e.g., terminal) checks to The AC&AT system identifies instruments and
determine, as appropriate, the validity of the makes them part of the authentication system. All
source of the data input or operational other devices must be authenticated through the
instruction. operating system.
11.10(i) Determination that persons who develop, Documentation on education, training and
maintain, or use electronic record/electronic experience of all Varian employees is preserved
signature systems have the education, at Varian Inc. as part of our ISO 9000 certification.
training and experience to perform their All projects document who is participating in the
assigned tasks. project.
Varian provides tutorials for self-learning of
workstation software.
Varian provides a training course for
administrators and users of the AC&AT and
workstation software.
11.10(j) The establishment of, and adherence to, NA – company SOPs
written policies that hold individuals
accountable and responsible for actions
initiated under their electronic signatures, in
order to deter record and signature
falsification.
11.10(k) Use of appropriate controls over system Operation manuals are distributed on the
documentation including 1. Adequate controls workstation software CD. The customer should
over the distribution of, access to, and use of exercise control over these. The only directly
documentation for system operation and accessible documentation about the system is in
maintenance. 2. system help.
Revision and change control procedures to
maintain an audit trail that documents time Installation of software revisions and updates are
logged in the security audit log. Only someone

Access Control and Audit Trail Software 61 03-914942-00:3

 Section Regulation Varian workstation functions
sequenced development and modification of with system maintenance rights can perform these
systems documentation. actions. These actions may also be limited by the
operating system settings.
11.30 Persons who use open systems to create, NA – All capabilities that relate to closed systems
modify, maintain, or transmit electronic also relate to open systems. The customer must
records shall employ procedures and controls write standard SOPs to account for the mixed use
designed to ensure that authenticity, integrity, of the system.
and, as appropriate, the confidentiality of
electronic records form the point of their
creation to the point of their receipt. Such
procedures and controls include those
identified in Sec 11.10, as appropriate and
additional measures such as document
encryption and use of appropriate digital
signature standards, to ensure, as necessary
under the circumstances, record authenticity,
integrity, and confidentiality.
11.50 Signature manifestations. NA
11.50(a) Signed electronic records shall contain Done through Adobe Acrobat.
information associated with the signing that
clearly indicates all of the following: 1. The
printed name of the signer, the date and time
when the signature was executed, and 3. The
meaning (such as review, approval,
responsibility, or authorship) associated with
the signature.
11.50(b) The items identified in paragraphs a1, a2 and Done through Adobe Acrobat.
a3 of this section shall be subject to the same
controls as for electronic records and shall be
included as part of any human readable form
of the electronic record (such as electronic
display or printout)
11.70 Electronic signatures and handwritten Done through Adobe Acrobat.
signatures executed to electronic records
shall be linked to their respective electronic
records to ensure that the signatures cannot
be excised, copied, or otherwise transferred
to falsify an electronic record by ordinary
means.
11.100 General requirements NA
11.100(a) Each electronic signature shall be unique to Done through Adobe Acrobat.
one individual and shall not be reused by, or
reassigned to, anyone else.
11.100(b) Before an organization establishes, assigns, NA – Related to company SOPs
certifies, or otherwise sanctions an
individual’s electronic signature, or any
element of such electronic signature, the
organization shall verify the identity of the
individual.
11.100(c) Persons using electronic signatures shall, NA – Related to company SOPs
prior to or at the time of such use, verify to
the agency that the electronic signatures in
their system, used on or after August 20,
1997, are intended to be the legally binding

Access Control and Audit Trail Software 62 03-914942-00:3

 Section Regulation Varian workstation functions
equivalent of traditional handwritten
signatures.
11.100(c1) The certification shall be submitted in paper NA – Related to Company SOPs
form and signed with a traditional handwritten
signature, to the Office of Regional
Operations, (HFC-100), 5600 Fisher Lane,
Rockville Md. 20857
11.100(c2) Personnel using electronic signatures shall, NA – Related to company SOPs
upon agency request, provide additional
certification or testimony that a specific
electronic signature is the legally binding
equivalent of the signer’s handwritten
signature.
11.200 Electronic signature components and NA
controls.
11.200(a) Electronic signatures that are not based upon At present there is no provision for Biometric
biometrics shall meet the following identification of individuals in the AC&AT software.
requirements Therefore, the following is not applicable.
11.200(a1) Employ at least two distinct identification Done through Adobe Acrobat.
components such as an identification code
and password
11.200(a1i) When an individual executes a series of Done through Adobe Acrobat.
signings during a single, continuous period of
controlled system access, the first signing
shall be executed using all electronic
signature components: subsequent signings
shall be executed using at least one
electronic signature component that is only
executable by, and designed to be used only
by, the individual.
11.200(a1ii) When an individual executes one or more Done through Adobe Acrobat.
signings not performed during a single,
continuous period of controlled system
access, each signing shall be executed using
all of the electronic signature components.
11.200(a2) Be used only by their genuine owners; and Done through Adobe Acrobat.

11.200(a3) Be administered and executed to ensure that Done through Adobe Acrobat.
attempted use of an individual’s electronic
signature by anyone other than its genuine
owner requires collaboration by two or more
individuals.
11.200(b) Electronic signatures based upon biometrics NA
shall be designed to ensure that they cannot
be used by anyone other than their genuine
owners.
11.300 Controls for identification code/passwords NA
Persons who use electronic signatures based
upon use of identification codes in
combination with passwords shall employ
controls to ensure their security and integrity.
Such controls shall include:

Access Control and Audit Trail Software 63 03-914942-00:3

 Section Regulation Varian workstation functions
11.300(a) Maintaining the uniqueness of each Done through Adobe Acrobat.
combined identification code and password,
such that no two individuals have the same
combination of identification code and
password.
11.300(b) Ensuring that identification code and Done through Adobe Acrobat.
password issuances are periodically check,
recalled, or revised (e.g. to cover such events
as password aging)
11.300(c) Following loss management procedures to NA
electronically de-authorize lost, stolen,
missing, or otherwise potentially
compromised tokens, cards, and other
devices that bear or generate identification
code or password information, and to issue
temporary or permanent replacements using
suitable, rigorous controls.
11.300(d) Use of transaction safeguards to prevent Done through Adobe Acrobat.
unauthorized use of passwords and/or
identification codes, and to detect and report
in an immediate and urgent manner any
attempts at their unauthorized use to the
system security unit, and as appropriate, to
organizational management.
11.300(e) Initial and periodic testing of devices, such as NA
token or cards, that bear or generate
identification code or password information to
ensure that they function properly and have
not been altered in an unauthorized manner.

Access Control and Audit Trail Software 64 03-914942-00:3

Appendix 4 – Tests for the Administrator Course for Varian
Access Control and Audit Trail Software
This Appendix contains four tests, the answer key, and a sheet for recording the results of the tests
for the self-learning course described in Section 6. These tests are also used for the course taught
by Varian representatives. Do not write on the material in this section. Copy the tests and a sheet for
recording the results of the testing, so that someone else may take the course. The material includes
a certificate that should be filled out by the student and the test administrator.

Access Control and Audit Trail Software 65 03-914942-00:3

Test for lesson 1
1) What is an implied right?
a) This is something so basic that everyone is allowed to do it
b) This is a simple right, like viewing a method that you can do because you have a more all
encompassing right like the ability to modify a method
c) This is a right that you have in the global project
d) None of the above
2) What is a global project?
a) A project that is available to everyone
b) A project that is associated with all instruments
c) A project that is used only by administrators
d) None of the above
3) Who can open a private lock?
a) The person who activated the lock
b) Any person authorized to use the applications that was locked
c) Any person authorized to convert a private lock to a public lock
d) All of the above
e) A & C
f) A&B
4) Who can open a public lock?
a) The person who activated the lock
b) Any person authorized to use the applications that was locked
c) Any person authorized to convert a private lock to a public lock.
d) All of the above
e) A & C
f) A&B
5) Does the administrator for the Access Control and Audit Trail software also have to be an
administrator for the operating system?
a) Yes
b) No
6) What is the default password for logging into the administration software?
a) Admin
b) Password
c) Chrom
d) (blank)
7) On the Policy page, what is the purpose of the User information titles?
a) Help remind the administrator what information should be entered for every user
b) Create the field name on the Users identification page
c) In a future release of the software, designate what information is printed with an electronic
signature
d) All of the above

Access Control and Audit Trail Software 66 03-914942-00:3

8) If the minimum password length is 4 and the minimum number of numeric characters is 5, which of
the following is true?
a) A password with 4 numbers will be accepted
b) The screen will generate an error when you try to save the new policy
c) A password with 5 number will be accepted
d) All of the above
9) Which of the following entries will be rejected by the software on the comments screen for a reason?
a) (two spaces)
b) (Enter)
c) I don’t know
d) None of the above
10) What does the application timeout setting do?
a) Sets the time that an application will be active without user input before it is private locked and
requires another login
b) Sets the time that an application will be active with or without user input before the application will
be private locked and require another login
c) Sets the time that an application will be active without user input before it is public locked and
requires another login
d) All of the above
11) How does this version of workstation software address electronic signatures?
a) The capability to add signatures to documents is built into the software
b) We recommend using Adobe Acrobat
c) We recommend using Microsoft Word
12) Can an instrument be assigned to two projects?
a) Yes
b) No
13) On the Policy page, you can set a reminder to archive the security audit log when it exceeds a certain
size. What are the units of that size?
a) Mbytes
b) K Bytes
c) Bytes
d) Entries
14) What is the maximum time limit for the application timeout?
a) 120 seconds
b) 999 seconds
c) 5 minutes
15) Can the system be set so that applications never time out?
a) Yes
b) No

Access Control and Audit Trail Software 67 03-914942-00:3

Test for lesson 2

1) Which of the following actions does the right to do system maintenance NOT automatically let you
do?
a) Add or update software in the workstation
b) Add or update users in the administration software
c) Fix a file whose audit trail has been corrupted
d) None of the above
2) If you had five workstations attached to the same network and you wanted to have them all share the
same security database, how many of them would you set to standalone operation?
a) 5
b) 1
c) 0
d) 2
3) When you apply an ID to a workstation that is part of a network, which workstation do you have to
make this input from?
a) The workstation with the security database on its local drive
b) The workstation that needs to have the ID applied to it
c) Any workstation
4) How many projects can be associated with one instrument?
a) 1
b) 4 at most
c) Any number
5) What is the effect of associating a project with a data directory?
a) When you log in with that project, you will ONLY be able to store raw data files in that directory
b) When you log in with that project, you will ONLY be able to store raw data files in that directory
and any subdirectories.
c) When you log in with that project, you will be prompted to store raw data files in that directory but
you will be able to select any directory for actual storage.
6) How many reasons can be entered into the list of reasons?
a) 10
b) An unlimited number
c) 100
d) 10 times the number of projects entered
7) How soon before a password expires will the system start to remind the user to change their
password?
a) 1 day
b) 2 days
c) 5 days
d) 7 days

Access Control and Audit Trail Software 68 03-914942-00:3

8) What page do you use to modify an individual users password expiration time from the system
password expiration time?
a) Policy page
b) Users page
c) Groups page
d) None of the above. All users must have the same password expiration time
9) If a user has the right to run with standards, do they also have the right to run without standards?
a) Yes
b) No
10) Can you enter the instrument ID number?
a) Yes
b) No
11) Can you enter the instrument name?
a) Yes
b) No
12) On the instruments page, which of the following are directly associated with an instrument?
a) Projects
b) Users
c) Groups
d) Workstations
e) A and D
f) B and C
g) All of the above
13) Can a user be assigned rights on both the global project and other projects?
a) Yes
b) No
14) When you are asked for a reason for an entry, can you enter both a preset reason and a free form
reason?
a) Yes
b) No
15) When you are going to change entries in the security database, do you have to be physically logged
into the workstation that has the security database on it?
a) Yes
b) No

Access Control and Audit Trail Software 69 03-914942-00:3

Test for Lesson 3
1) Which of the following are the files that contain internal versions?
a) Method file
b) Sequence file
c) Sample list file
d) Data file
e) All of the above
f) A and D
g) A, C and D
2) How can you protect a method from being modified while allowing a new method to be created from
that method?
a) Do not give anyone but yourself the right to modify methods
b) Password protect existing methods
c) Do not give anyone but yourself the right to view methods
3) What entry in a method is directly above the Version information in the method section tree display?
a) Method name
b) Pump parameters
c) Method notes
4) Does the “Save As” function create a new version in the method?
a) Yes
b) No
5) Where can you select the version of the calculated results that you want to view, in either Interactive
Graphics or MS Data Review?
a) When you first open a data file
b) On the “File” pull down menu
c) On the “View” pull down menu
d) A and C
6) Is a version of the results stored every time that you move a baseline?
a) Yes
b) No
7) Is a version of the results stored every time that you do a recalculation?
a) Yes
b) No
8) When are you asked for a reason for the change in data processing when you are doing manual
recalculations?
a) When you do the recalculation
b) When you more the baselines
c) When you exit Interactive Graphics, or the manual recalculations screens in MS Data Review

Access Control and Audit Trail Software 70 03-914942-00:3

9) What are some of the functions that make it possible to tell when an archived System Log has been
destroyed or moved to another location?
a) System logs are no longer sequentially numbered
b) The time of the last entry in one log does not correspond to the time of the first entry in next log
c) The person who archived the system log is not the person who created the new system log
d) All of the above
10) What is the maximum number of versions that can be added to a method?
a) 10
b) 25
c) Unlimited
d) 99
11) Which of the following actions will NOT be entered into the system log
a) Creating a new version of a method file
b) Staring an automated run
c) Changing the configuration of the instruments
d) Private locking an instrument in System Control
12) Can you run and collect data using an older version of a method?
a) Yes
b) No
13) Can you add versions to a method that was created with an older version of workstation software?
a) Yes
b) No
14) How do you know by looking at the System Control screen that an instrument is private locked?
a) The words “private lock” are displayed in the instrument screen on the configuration screen
b) A picture of a lock is displayed in the instrument screen on the configuration screen
c) There is no display until you try to access the instrument itself
15) When the System Log is archived, do you have to create a new log file?
a) Yes
b) No, the software automatically creates a new log file

Access Control and Audit Trail Software 71 03-914942-00:3

Test for Lesson 4
1) If you are not familiar with the Star or MS workstation, where do you find information about it basic
operation?
a) On the Workstation CD
b) In the Access Control and Audit Trail software Operation manual
c) On the Varian Inc. website
d) All of the above
2) What software validation tool has been shipped with previous Varian Star and MS workstation
software versions?
a) Test plan for testing the workstation software in the customer’s lab
b) Results of our testing the workstation software at CSB
c) Validate program that compares checksums for workstation files against a standard
d) All of the above
3) When an administrator adds a user to the system, when should the user enter their password?
a) The first time that they use the system
b) When they are specified to do in the laboratory SOP
c) Immediately after the administrator enters their login name
4) What is the suggested range for the minimum length of a password?
a) 6 to 10 characters
b) Anything above 6 characters
c) An even number of characters
d) Twice the minimum number of numeric characters
5) If you change the password for the default login name, admin, why must you remember it?
a) It is the only way for a service person to access the administration software
b) It is the only way for a service person to update the software
c) It is the only access to the system if all of the accounts of all of the workstation administrators
have been disabled
d) You will only be able to change the default password by logging in through the default login.
6) What is the first thing that we advise administrators who are new to this software, to do when they are
first setting up the software?
a) Read the manual
b) Take a training course form the local Varian service person
c) Take the self-teaching course
d) Any and all of the above
7) When using a network of workstations sharing the same security database, why do you want to
initially make all of the entries on the standalone workstation?
a) It is easier to do this
b) The standalone workstation will usually not be in the laboratory
c) The standalone workstation automatically has the security server database created on it.
d) The standalone workstation will usually be in a secure location
8) What other information will you enter on the entry form in the Appendix of this manual, when you
enter the workstations?
a) Reasons
b) Instruments
c) Users
d) Users and Groups

Access Control and Audit Trail Software 72 03-914942-00:3

9) Can you delete the preset reasons?
a) Yes
b) No
10) Where do you associate workstations with projects?
a) Form D
b) The Workstations page of the Administration software
c) The Projects page of the software
d) Nowhere - you do not directly associate workstations with projects, you only associate
instruments with projects
11) When you log into the Administration software for the first time and create your own login name and
password, why should you immediately validate the entry and close the software
a) The location of the security database will be set
b) So that you can log in as yourself, creating the proper identification in the audit trail
c) To make sure that the audit trail file is initially created correctly
d) All of the above
12) What are the advantages of having a new user enter their password immediately after the
administrator has created their login name?
a) There is never a time when a user login name has a password that is known to the administrator
b) The user will be able to ask the administrator questions about what the best password would be
c) The identity of the user is confirmed by the administrator
d) A and B
e) A and C
f) B and C
g) All of the above
13) Why should policies, such as how many incorrect logins will be needed to cause an account to be
disabled, be part of the lab SOP?
a) So that the administrator can justify what they enter to the users
b) So that the administrator knows exactly what to enter in each column
c) So the there is consistency in the lab between different administrators
14) Why is this manual in a ring binder rather than spiral bound?
a) To make the material seem more impressive when a regulator examines the material
b) To make sure that it stands up on the bookshelf easily
c) To make it easy to copy the forms in the back
15) Why do you add projects to the system before you add users?
a) When you give a user rights, you give them rights on a project and those projects must have
been built previous to doing this
b) Adding projects is less complex than adding users so you can get some practice in working with
the software before adding users
c) The Projects page is the first screen displayed when the administration software is accessed

Access Control and Audit Trail Software 73 03-914942-00:3

Answers for Tests 1 through 4

Test # 1 2 3 4
Question #
1 B B F A
2 B B B C
3 E B C B
4 F C B A
5 B C B C
6 C B B D
7 D C B C
8 C B C B
9 D A D A
10 C B C D
11 B A A B
12 A E A E
13 B A A C
14 B A B C
15 A B B A

Access Control and Audit Trail Software 74 03-914942-00:3

Appendix 5 - Forms for Getting Started to Set-up Security
Administration Software
The forms in this section should be used in conjunction with the individual steps in section 7 –
Getting Started. These forms allow the user to enter information that will then be put into the security
administration software. It is easier to decide on what will be entered before you begin making
entries than to do it while you are making the entries. This will allow you to consider the overall plan
for the system configuration.

Form A – Selecting the Local Workstation for Standalone or Network

Operation.

Access Control and Audit Trail Software 75 03-914942-00:3

Form B – Entering Policies Using the Policy Page

Access Control and Audit Trail Software 76 03-914942-00:3

Form C – Workstation and Instrument Entry Form
Workstation operating locally and containing the security database and log.

Workstation name
Instrument 1 name
Instrument 2 name
Instrument 3 name
Instrument 4 name

Workstations using the security server on the above workstation.

Workstation name
Instrument 1 name
Instrument 2 name
Instrument 3 name
Instrument 4 name

Workstation name
Instrument 1 name
Instrument 2 name
Instrument 3 name
Instrument 4 name

Workstation name
Instrument 1 name
Instrument 2 name
Instrument 3 name
Instrument 4 name

Workstation name
Instrument 1 name
Instrument 2 name
Instrument 3 name
Instrument 4 name

Note: Default instrument names are automatically created when a workstation is created. The
default names are of the form (Workstation name)_1 to (Workstation name)_4. If you wish to keep
the default name, enter default in the spaces above.

Note: If all of your workstations are going to operate off of their own security database and server,
you can use the network entries on this form to enter their names.

Access Control and Audit Trail Software 77 03-914942-00:3

Form D – Project Entry and Instrument Association Form
Enter the project along the top row and the Instruments below each project.

Project
Instrument

Projects
Instruments

Projects
Instruments

Access Control and Audit Trail Software 78 03-914942-00:3

Form E – Reason Entry Form
The first 10 reasons are reasons preset in the Security Administration software. These may be
deleted if desired.
Incorrect baseline assignment
Incorrect peak assignment
Initial system setup
Methods development
Method validation
New instrumentation added to the system
New project
New user added to organization
User assignment changed
User left organization

Access Control and Audit Trail Software 79 03-914942-00:3

Form F – Individual user information Entry Form
Enter the user information titles that you entered on Form B in the Policy page in rows 1 – 4, and
then enter the appropriate information for each user.

User login name

Use full name
Individual password
expiration date
1
2
3
4

User login name

Use full name
Individual password
expiration date
1
2
3
4

User login name

Use full name
Individual password
expiration date
1
2
3
4

Access Control and Audit Trail Software 80 03-914942-00:3

Form G – User Groups
Use this to group individual users (created using Form F).
Group
Users

Group
Users

Group
Users

Access Control and Audit Trail Software 81 03-914942-00:3

Form H – User or Groups/Project Rights Entry Form
Note: Rights granted in the Global project will apply to all projects with which a user is
associated.
User or Group
Project
System
Administrator
System maintenance
Unlock private locks

Data and Results

View data
Recalc data
Batch recalc
Sign/Approve

Methods
View
Modify
Delete

MS Instrument
AutoTune an MS
Manually Tune an MS
Exec. 1200MS Macros
Edit 1200MS Macros

Instrument
View Status
Configure
Run without standards
Run with standards

Access Control and Audit Trail Software 82 03-914942-00:3

Software Certificate of Compliance
Varian Chromatography Systems certifies that its Star and Saturn workstation software
products are defined, designed, tested and manufactured according to its Quality System
procedures. Our Quality System has received ISO 9001 certification number FM21797.

Software development follows the life cycle approach. Market and scientific research
leads to a formal Product Definition. The Product Definition is used to produce System
Functional Requirements and Software Requirement Specifications documents. The Software
Requirement Specifications are then used to design the software. The software is tested against
the Product Definition and the Software Requirement Specifications.

Each product has a formal written Test Plan. The Test Plan identifies specific tests to be
performed and the acceptable results that must be achieved. The Test Plan verifies that the
software performs as defined in the Product Definition, including all algorithms and
computations. All or portions of the Test Plan are executed at various points in the development
process to determine the product's compliance with the Requirements documents. The entire Test
Plan is always executed on the final software version. All significant deviations from the Product
Definition that are found in the final software version are either corrected or are documented in
the Release Notes supplied with the product. The Test Plan and the test results for the final
software version released as the product are maintained in the Quality Documentation archived
for each product.

Varian Chromatography Systems will make its software documentation for Star and
Saturn workstations available for inspection at its Walnut Creek facility as required by
government regulations.

This Software Certificate of Compliance is not a warranty nor is it intended to be in lieu

of any government-mandated testing requirements applicable to specific customer uses of
equipment or software. Warranties on Varian software products are expressly in lieu of and
exclude all other expressed or implied warranties, including but not limited to warranties of
merchantability and of fitness for a particular purpose, use or application, and all other
obligations or liabilities on the part of Varian, unless such other warranties, obligations or
liabilities are expressly agreed to in writing by Varian.

03-914450-00:11 1 of 1