Agilent MassHunter Compliance

Administrator Guide

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In This Guide...

In This Guide... In the Compliance mode, MassHunter GC/MS Acquisition and Quantitative Analysis, in
conjunction with Agilent OpenLab Enterprise Content Manager (ECM), supports the
requirements of the U.S. Food and Drug Administration (FDA) regulations on the handling
of electronic records and electronic signatures published as 21 CFR Part 11. Records are
treated as regulated records.

This book describes how to set up and use MassHunter GC/MS Acquisition B.07.03 and
MassHunter Quantitative Analysis B.07.01, in the Compliance mode. OpenLab ECM version
3.4.1 SP2 or higher is required to support MassHunter Compliance mode.

NOTE: The Compliance mode does not support Qualitative Analysis.

1. Agilent OpenLab ECM - Chapter 1 describes the general steps you should follow to set up ECM when used with
Overview MassHunter GC/MS Acquisition and Quantitative Analysis running in the Compliance
mode. It also details the differences between retrieving and checking out a file directly
from ECM.

Details for setting up and managing ECM users, groups, roles, etc, are beyond the scope of
this document. Those details are included in the OpenLab ECM Online Help.

2. MassHunter GC/MS Chapter 2 describes how to install MassHunter GC/MS Acquisition in Compliance mode,
Acquisition - Setup and depending on which version is currently installed. It then details how to assign users to
Configuration Windows security groups and configure instruments and settings.

3. MassHunter GC/MS Chapter 3 describes routine tasks performed in MassHunter GC/MS Acquisition in
Acquisition - Routine Tasks Compliance mode.

4. MassHunter Quantitative Chapter 4 provides general guidance on how to install and set up MassHunter Quantitative
Analysis - Setup and Analysis depending on which version is currently installed. It then details how to associate
Configuration ECM roles with MassHunter Quantitative Analysis command groups.

5. MassHunter Quantitative Chapter 5 describes routine tasks performed in MassHunter Quantitative Analysis in
Analysis - Routine Tasks Compliance mode.

6. Audit Trails Chapter 6 describes how to view or print audit-trail logs and how to enable or disable the
audit reasons shown in logs in both MassHunter GC/MS Acquisition and Quantitative
Analysis.

3
In This Guide...

7. MassHunter Quantitative Chapter 7 provides a complete list of all the commands in each MassHunter Quantitative
Analysis Command Groups Analysis command group: Batch Analysis, Method Development, Batch Review, and
Report.

8. MassHunter Acquisition Chapter 8 provides a list of the default privileges assigned to the pre-defined Windows security
Windows Security Groups groups Analyst I, Analyst II, Analyst III, and Manager which are used in MassHunter GC/MS
Acquisition. The permissions are grouped by their function.

9. Supported Network Topologies Chapter 9 includes examples of the network configurations supported by MassHunter
for Compliance Security Mode compliance mode.

All supported configurations require an ECM server installation of version 3.4.1 SP2 or
greater.

Where to find more information In addition to MassHunter’s online Help, the Federal Registry 21 CFR Part 11, and the ECM
documentation accompanying your hardware and software, Agilent also provides a
comprehensive collection of:
• Manuals
• Videos
• User Applications
• Method development tools
• A MassHunter GC/MS Software Compliance Assessment document

These are located on the:

• Agilent GC and GC/MS Manuals and Tools DVD set or Agilent Hardware DVD
• Agilent GC/MS Software Information and Manuals memory stick

To Install Your Hardware Library

Version B.01.05
January, 2013
Agilent Technologies
GC/GCMS Hardware User Manuals and Videos

Agilent Technologies
Disk 2/3
Insert Disk 1 into your DVD drive and follow the prompts.
GC/GCMS Hardware User
To install: Manuals and Videos
1. Insert disk into DVD drive
2. Follow the instructions on the screen.
3. If autoplay is not enabled, double-click
"index_xx.html" on the DVD
where xx is:
Version B.01.05 en for English Disk 2/3
ch for
January, 2013 jp for
To install:
1. Insert disk into DVD drive
2. Follow the instructions on the screen.
© 2013 Agilent Technologies, Inc.3. If autoplay is not enabled, double-click
All rights reserved. "index_xx.html" on the DVD

This can be installed by anyone who has authority to copy

Made in USA where xx is:
en for English

S1
ch for
jp for

© 2013 Agilent Technologies, Inc.

All rights reserved.
Made in USA

S1
information onto the receiving computer.

To Install Your Software Library

Insert the memory stick into a USB port and follow the prompts.

This can be installed by anyone who has authority to copy

information onto the receiving computer.

4
Contents
In This Guide... 3

1 Agilent OpenLab ECM - Overview

Introduction 10
Set up the ECM server 11
Install the ECM Workstation Client 13
Test User’s ECM Credentials 15
Retrieve Versus Checkout 15

2 MassHunter GC/MS Acquisition - Setup and Configuration

Review the Installation and Setup Steps 18
Assign Users to a Windows security group 22
Installation where no previous version of MassHunter GC/MS Acquisition is
installed 24
Installation where MassHunter GC/MS Acquisition is installed in the Standard
Workflow mode 25
Installation where MassHunter GC/MS Acquisition is installed in the User
Management and Audit Trail mode 26
Configure an Instrument 27
Set the Password Reset Interval 28
Set the Idle Timeout Interval 29

3 MassHunter GC/MS Acquisition - Routine Tasks

Manually Lock and Switch Users 32
Review User Access Privileges 32
Understand ECM Storage Locations and File Types 33
Save and Retrieve Data, Methods, and Sequence Files 34
Change the ECM Storage Locations 35
Test the Communication with the ECM Server 36
View the Current LCDF path to the ECM Server 37
Open the ECM Server via Internet Explorer 38
Import a Method from a Location Outside the ECM Server 39

4 MassHunter Quantitative Analysis - Setup and Configuration

Review the Installation and Setup Steps 42
Installation where there was no previous version of MassHunter Quantitative
Analysis 43
Installation where MassHunter Quantitative Analysis B.07.01 is installed in the
Standard Workflow mode 44
Installation where MassHunter Quantitative Analysis B.07.01 is installed in the User
Management and Audit Trail mode 45

5
 Installation where an older version of MassHunter Quantitative Analysis is installed
(pre B.07.01) 46
Associate ECM Roles to MassHunter Quantitative Analysis Command Groups 47

5 MassHunter Quantitative Analysis - Routine Tasks

Review User Access Privileges 52
Understand ECM Storage Locations and File Types 52
Access Files from Quantitative Analysis 53
Add Quantitative Analysis Report Templates to ECM 53

6 Audit Trails
GC/MS Acquisition - Enable/Disable Audit Reasons 56
GC/MS Acquisition - Edit the Pre-defined “Reason for Change” List 57
GC/MS Acquisition - View Instrument Audit Trail 58
GC/MS Acquisition - View and Print a Method Audit-Trail Log 58
GC/MS Acquisition - View and Print a Sequence Audit-Trail Log 59
GC/MS Acquisition - View and Print an Instrument Configuration Audit-Trail
Log 59
Quantitative Analysis - Audit Trail Overview 60
Quantitative Analysis - Generate an Audit Report 61
Quantitative Analysis - Enable/Disable Audit Reasons 63

7 MassHunter Quantitative Analysis Command Groups

Overview 68
Batch Analysis Command Group 69
Method Development Command Group 70
Batch Review Command Group 71
Report Command Group 71

8 MassHunter Acquisition Windows Security Groups

Overview 74
Method Menu 74
Sequence Menu 75
GC - Instrument Menu 75
MS - Instrument Menu 76
CTC/PAL - Instrument Menu 76
Miscellaneous Instrument Menu 77
View Menu 77
Batch Menu 78
Checkout Menu 78
Change Group Privileges 79

6
9 Supported Network Topologies for Compliance Security Mode
Single GC/MS Workstation (Acquisition PC) 82
GC/MS Workstation (Acquisition PC) Plus a Data Review Station (Review PC) 82
GC/MS Workstation (Acquisition PC) Plus Data Processing (Process PC) Plus Data
Review (Review PC) 83
Scaled Network Solution Multiple GC/MS Systems 83
Scaled Network Solution Multiple GC/MS Systems + Multiple Processing and
Review Stations 84

7
8
1
Agilent OpenLab ECM - Overview
Introduction 10
Set up the ECM server 11
Test User’s ECM Credentials 15
Install the ECM Workstation Client 13
Retrieve Versus Checkout 15

Chapter 1 describes the general steps you should follow to set up ECM when
used with MassHunter GC/MS Acquisition and Quantitative Analysis running in
the Compliance mode. It also details the differences between retrieving and
checking out a file directly from ECM.

Details for setting up and managing ECM users, groups, roles, etc, are beyond
the scope of this document. Those details are included in the OpenLab ECM
Online Help.
1. Agilent OpenLab ECM - Overview Introduction

Introduction OpenLab ECM version 3.4.1 SP2 must be installed and tested prior to installing
MassHunter.

When using MassHunter in the Compliance mode, all regulated records are stored in ECM,
with digital signatures being applied using ECM.

The workstation on which MassHunter is running must be connected to an ECM server

(version 3.4.1 SP2 or greater) and the ECM client must be installed on the workstation and
be operational.

MassHunter GC/MS Acquisition and MassHunter Quantitative Analysis programs must

both be configured to the same ECM database account.

Users of both MassHunter GC/MS Acquisition and Quantitative Analysis require an ECM
user account on the ECM database account that is configured for their MassHunter
workstation.

ECM stores user IDs and privileges that apply to the ECM database as well as to the
MassHunter GC/MS Acquisition and Quantitative Analysis programs.

ECM user account information can be authenticated directly by ECM (Built-In) or by a

Windows Domain server.

MassHunter GC/MS Acquisition running in the Compliance mode uses Windows security
groups on the local MassHunter workstation to associate Windows users with MassHunter
privileges.
• A GC/MS Acquisition user is assigned to an ECM user group, and the group is then
assigned to a Windows security group.
• The Agilent GCMS Configuration Editor associates MassHunter GC/MS Acquisition
commands with these Windows security groups.

MassHunter Quantitative Analysis running in ECM Compliance mode uses roles created
in ECM to associate users with MassHunter privileges. For MassHunter Quantitative
Analysis:
• A Quantitative Analysis user is assigned to an ECM user group, and the group is then
assigned to an ECM role.
• The MassHunter Audit Trail Map (ATM) program associates MassHunter Quantitative
Analysis command groups to ECM roles.

10
1. Agilent OpenLab ECM - Overview Set up the ECM server

Set up the ECM server Follow these steps to prepare your OpenLab ECM for use with MassHunter Compliance
mode.

Details for setting up and managing ECM users, groups, roles, etc, are beyond the scope of
this document. Those details are included in the OpenLab Enterprise Content Manager
Administrator's Guide. Please refer to that document for complete details.

1. Create an ECM database account A single ECM database account is required to allow sharing of users across 
for MassHunter workstations. MassHunter GC/MS Acquisition, Quantitative Analysis, and ECM.

ECM privileges will be used to control access to database folder Locations from
MassHunter.

MassHunter GC/MS Acquisition and MassHunter Quantitative Analysis, must both be

configured to the same ECM database account.

2. Set up MassHunter users in Both MassHunter GC/MS Acquisition and Quantitative Analysis require that every user be
ECM. identified in ECM and granted ECM file privileges.

ECM Users can be added through the ECM built in account or from your Windows Domain
users list.

3. Create ECM user groups for Consider how you organization will be operating and create appropriate groups in ECM for
MassHunter Quantitative Quantitative Analysis users. Then assign users to each group.
Analysis users and add members
to the groups. Two such groups could be:
• Developers = Who could have access to all Quantitative Analysis commands.
• Analysts = Who could have access to just a part of the Quantitative Analysis
commands.

4. Create ECM user groups for Similar to the groups you established for Quantitative Analysis users, create appropriate
MassHunter GC/MS Acquisition groups for the Acquisition users. Then assign users to this group. A typical group could be:
users. • MassHunter GC/MS Acquisition Users.

5. Create ECM Quantitative Two such roles could be:

Analysis roles and add • Developers = Who could have access to all Quantitative Analysis privileges. See
Quantitative Analysis groups to “Sample ECM Developer Role for Quantitative Analysis” on page 12.
these roles.
• Analysts = Who could have access to just a part of the Quantitative Analysis
commands. See “Sample ECM Analyst Role for Quantitative Analysis” on page 13.

11
1. Agilent OpenLab ECM - Overview Set up the ECM server

6. Assign the built in ECM In addition to assigning users to the custom roles (such as Developer and Analyst), also
Contributor role to both include them in the built-in ECM role entitled:Contributor. The Contributor role contains
MassHunter GC/MS Acquisition ECM privileges such as:
and MassHunter Quantitative
• File reading
Analysis users or groups.
• File Creation
• File retrieving

Sample ECM Developer Role for This role could allow a developer access to all the Quantitative Analysis commands.
Quantitative Analysis

12
1. Agilent OpenLab ECM - Overview Install the ECM Workstation Client

Sample ECM Analyst Role for This role could allow the analyst access to all commands except those required for editing
Quantitative Analysis the Quantitation method.

Install the ECM Workstation After the ECM server is installed and accessible over a network from the MassHunter
Client workstation, you can install the ECM workstation client as described below.

1. Gather the following from the Record your details here for future reference, if desired.
ECM server Administrator.

Item Typical Value Your Values

ECM Server URL http://ECMServerName/ecm
ECM Username UserName
ECM Password *************
ECM Account ABCD
Domain Local or Domaina
ECM LCDF location GCMSb

a. If you do not have a corporate domain, ECM supports a “Built-in” domain.

b. In ECM file system terminology, this could be an L, LC, LCD, or LCDF depending on your ECM storage
structure.

2. From Internet Explorer, go to the An ECM Login screen is displayed.

ECM server URL.

13
1. Agilent OpenLab ECM - Overview Install the ECM Workstation Client

3. Enter a valid user name,

password, account, and domain
provided by the ECM account
Administrator, and click Login.

4. ECM Components are The first time you access the ECM server from the computer where your MassHunter
downloaded. workstation is installed, the ECM server will download and install the following components
onto the MassHunter workstation:
• Agilent OpenLab ECM API
• Agilent OpenLab ECM Client
• Agilent OpenLab ECM Resources

We recommend you do not install the ECM Scheduler or ECM Cyberprinter because the
MassHunter GCMS Acquisition software is not tested with these components.

5. To complete the installation,

restart your machine.

14
1. Agilent OpenLab ECM - Overview Test User’s ECM Credentials

Test User’s ECM Credentials To verify file access rights are properly configured in both Windows and ECM, have each
user do the following before attempting to log in to MassHunter.

1. Log into the workstation.

2. Open Internet Explorer and go to

the ECM URL.

3. Create a folder within their

assigned ECM environment.

4. Upload a file to their assigned

ECM environment.

Retrieve Versus Checkout When users log into ECM directly from Internet Explorer, they may, depending on their
privilege, be able to retrieve or checkout a file.
• Retrieved files are not locked in ECM. 
The file in ECM is still available to anyone else.
• Checked out files are locked in ECM. 
Only the individual who checked out the file can check the file back in to ECM, or undo
the Checkout. However, with appropriate permissions, users may retrieved a copy of a
checked out file.

Important! Please remember that users can access and check out files from ECM in two ways:
• By logging in to ECM via Internet Explorer
• By logging in to ECM via MassHunter

Regardless of how a user accesses ECM, files that are checked out of ECM remain
unavailable to MassHunter until they are checked back in to ECM, or the checkout is
canceled. A batch file that is checked out can be accessed as Read-Only.

If a file is checked out by anyone, and MassHunter GC/MS Acquisition attempts to load
that file, a message similar to the following is displayed.

In MassHunter GC/MS Acquisition, files (methods, sequences, and mass spectral data)
are automatically checked in to ECM.

Files downloaded from ECM by GC/MS Acquisition (e.g., methods and sequences) are
retrieved, by default. They are not checked out and locked.

15
1. Agilent OpenLab ECM - Overview Retrieve Versus Checkout

To retrieve a file:

1. Add the ECM server to the list of In Internet Explorer, select Tools > Internet Options > Security > Trusted Sites > Sites. In
Trusted Sites in Internet Explorer the window that appears, uncheck Require server verification (https:) for all sites in this
on your workstation. zone. In the Add websites to the zone: field, type the URL for your ECM server and click
Add. Click Close > OK. Restart Internet Explorer to apply the changes.

2. Access the file in OpenLab ECM

Explorer via Internet Explorer.

3. Right-click and select Retrieve.

4. Navigate to the designation • The file is copied to your selected destination.

folder and click OK. • The file in ECM is still available to anyone else.

See your ECM documentation for more complete details on using the checkout option in
ECM.

16
2
MassHunter GC/MS Acquisition -
Setup and Configuration
Review the Installation and Setup Steps 18
Assign Users to a Windows security group 22
Installation where no previous version of MassHunter GC/MS
Acquisition is installed 24
Installation where MassHunter GC/MS Acquisition is installed in the
Standard Workflow mode 25
Installation where MassHunter GC/MS Acquisition is installed in the
User Management and Audit Trail mode 26
Configure an Instrument 27
Set the Password Reset Interval 28
Set the Idle Timeout Interval 29

Chapter 2 describes how to install MassHunter GC/MS Acquisition in

Compliance mode, depending on which version is currently installed. It then
details how to assign users to Windows security groups and configure
instruments and settings.
2. MassHunter GC/MS Acquisition - Setup and Configuration Review the Installation and Setup Steps

Review the Installation and

Setup Steps

1. Verify the prerequisites. Before installing MassHunter GC/MS Acquisition in Compliance mode, ensure:
• The LAN is an Agilent supported LAN (page 81) layout.
• You are logged on with Local Windows Workstation Administrator credentials.
• The PC is running under Windows 7 Professional SP1 (64-bit).
• The standalone ECM (3.4.1 SP2) server is operational.
• Agilent OpenLab ECM - Overview (Page 9) has been set up for MassHunter GC/MS
Acquisition and MassHunter Quantitative Analysis.
• The ECM client (page 13) has been installed on the MassHunter workstation.

2. Select your installation type, and NOTE: Details for installing MassHunter GC/MS Acquisition are included in the Agilent
Install MassHunter GC/MS MassHunter Workstation Offline Qualitative and Quantitative Analysis for GCMS
Acquisition. Installation Guide.

The instructions here provide general guidance only. Please refer to the above document
for complete installation details.

There are three general conditions under which you may be installing MassHunter GC/MS
Acquisition in Compliance mode. See the pages listed below for details on your particular
setup.
• The workstation has no previous version of MassHunter GC/MS Acquisition Installed
(page 24).
• The workstation has MassHunter GC/MS Acquisition installed in the Standard
Workflow mode (page 25).
• The workstation has MassHunter GC/MS Acquisition installed in the User Management
and Audit Trail mode (page 26).

3. Review Windows security groups During installation, MassHunter GC/MS Acquisition created four Windows security groups:
and privileges. • Acquisition Analysts I
• Acquisition Analysts II
• Acquisition Analysts III
• Acquisition Managers

Each of these groups has a different set of access privileges (called Roles and
Responsibilities).
• The highest level group is Manager. This group has access to all privileges. Each lower
level group has a subset of the privileges of the next higher level.
• The lowest level group is Analyst I.

18
2. MassHunter GC/MS Acquisition - Setup and Configuration Review the Installation and Setup Steps

Before assigning users to groups, review the default privileges assigned to each group and
edit the privileges, if required, for your organization.

See “MassHunter Acquisition Windows Security Groups” on page 73.

See “Change Group Privileges” on page 79 for details on how to change these settings.

MassHunter GC/MS Acquisition also created a new user "GCMSCFR11" as part of the
local administrator group. This user has the needed windows privileges to run the
MassHunter GC/MS Acquisition application, and the Configuration Editor. Task manager
here shows that the user GCMSCFR11 is running the msinsctl.exe (MassHunter GC/MS
Acquisition) program.

19
2. MassHunter GC/MS Acquisition - Setup and Configuration Review the Installation and Setup Steps

4. Assign each user to a group. After reviewing the four MassHunter GC/MS Acquisition Windows security groups, assign
each user to one of the groups.

See “Assign Users to a Windows security group” on page 22 for details on how to do this.

REMEMBER: Before a user can access MassHunter GC/MS Acquisition, they must:
• Be assigned to one of the four MassHunter Windows security groups. (page 22) The
userID and Password must be the same as those set up for this user in ECM.
• Have a valid ECM user account. Refer to your ECM documentation for details on how to
set up ECM user accounts.

If either one of these two requirements is missing, users will not be able to access MassHunter
GC/MS Acquisition.

5. Configure one instrument. After you have installed the ECM components and MassHunter GC/MS Acquisition on
your workstation, you may configure one instrument. See “Configure an Instrument” on
page 27 for details.

6. Create the initial LCDF structure. After configuring ECM on the ECM server, and downloading the ECM components to the
workstation, the first time you login to MassHunter GC/MS Acquisition as the
Administrator, you will be presented with a series of screens to identifying the ECM server
path for your Data, Methods, Sequences, Tune Evaluations, and Air and Water reports.

This first screen identifies where in ECM your Data will be saved. This will be followed by a
screen for methods, sequences, tune evaluations, and air and water.

• To accept the default and continue, click OK. If the path is not already set up in ECM,
the system will set it up now and display the next screen. This may take several seconds.
• To create a new Cabinet, Directory or Folder in ECM, and click Browse to access ECM
and create the path.

7. Tune the instrument. At the completion of the wizard, tune the instrument. Initializing the instrument will have
overwritten the default tune, atune, etune, etc.

20
2. MassHunter GC/MS Acquisition - Setup and Configuration Review the Installation and Setup Steps

8. Configure MassHunter GC/MS To complete your installation process, access the Configuration Editor, and:
Acquisition.
• Configure an instrument (page 27)
• Set the User Password Reset interval (page 28)
• Set the Idle Timeout interval for MassHunter GC/MS Acquisition (page 29)
• Review Roles and Responsibilities (page 73)
• Enable/Disable Audit Reasons (page 56)
• Edit the Pre-defined "Reason for Change" List (page 57)

9. Assign users to a Windows The privileges each user has in MassHunter GC/MS Acquisition are based on the
security group. Windows security group to which they have been assigned. After you have reviewed the
roles and responsibilities associated with these groups, assign each MassHunter GC/MS
Acquisition user to one of the groups. See “Assign Users to a Windows security group” on
page 22.
• To review the default privileges, see “MassHunter Acquisition Windows Security
Groups” on page 73.
• See “Change Group Privileges” on page 79 for details on how to change these defaults.

21
2. MassHunter GC/MS Acquisition - Setup and Configuration Assign Users to a Windows security group

Assign Users to a Windows

security group

1. Click Start then type edit local

and press Enter.

2. The Local Users and Groups

dialog displays. Double-click
groups.

22
2. MassHunter GC/MS Acquisition - Setup and Configuration Assign Users to a Windows security group

3. To add local or domain users to

the Acquisition Groups, double-
click the group to which the user
needs to be added, and click add.

• If adding a domain user and the domain is not shown in From this location, click
Locations and select the domain name.
• If adding a local user and the workstation is not shown in From this location, click
Locations and select the workstation name.

4. Enter the user id and click Check

Names. If the user id entered is
correct, then click OK. In this
example, the updated user name
would be under the Acquisition
Managers properties.

5. Click Apply to update the page.

23
2. MassHunter GC/MS Acquisition - Setup and Configuration Installation where no previous version of

Installation where no NOTE: Details for installing MassHunter GC/MS Acquisition are included in the Agilent
previous version of MassHunter Workstation Offline Qualitative and Quantitative Analysis for GCMS
Installation Guide. The instructions here provide general guidance only. Please refer to the
MassHunter GC/MS above document for complete installation details.
Acquisition is installed
There are three general conditions under which you may be installing MassHunter GC/MS
Acquisition in Compliance mode. See the pages listed below for details on your particular
setup.
• The workstation has no previous version of MassHunter GC/MS Acquisition Installed
(shown below, on this page) (page 24).
• The workstation has MassHunter GC/MS Acquisition installed in the Standard
Workflow mode (page 25).
• The workstation has MassHunter GC/MS Acquisition installed in the User Management
and Audit Trail mode (page 26).

To install MassHunter GC/MS Acquisition B.07.03 in the Compliance mode on a

workstation that has no previous version of MassHunter GC/MS Acquisition installed:

1. Insert the DVD and follow the

prompts to access this screen.

2. Select Activate Compliance, and

click Next to continue.











3. During the installation of After you reboot and log in to your PC, the Installation wizard will proceed to complete the
MassHunter GC/MS Acquisition, installation of the required Windows components.
you may be prompted to install or
update some Windows
components and reboot your PC.

24
2. MassHunter GC/MS Acquisition - Setup and ConfigurationInstallation where MassHunter GC/MS Acquisition

Installation where NOTE: Details for installing MassHunter GC/MS Acquisition are included in the Agilent
MassHunter GC/MS MassHunter Workstation Offline Qualitative and Quantitative Analysis for GCMS
Installation Guide. The instructions here provide general guidance only. Please refer to the
Acquisition is installed in above document for complete installation details.
the Standard Workflow
mode There are three general conditions under which you may be installing MassHunter GC/MS
Acquisition in Compliance mode. See the pages listed below for details on your particular
setup.
• The workstation has no previous version of MassHunter GC/MS Acquisition Installed
(page 24).
• The workstation has MassHunter GC/MS Acquisition installed in the Standard
Workflow mode (shown below, on this page) (page 25).
• The workstation has MassHunter GC/MS Acquisition installed in the User Management
and Audit Trail mode (page 26).

If MassHunter GC/MS Acquisition B.07.03 is already installed on your workstation in the

Standard Workflow mode, you may use this procedure to activate the MassHunter GC/MS
Acquisition B.07.03 Compliance mode.

Note: If MassHunter GC/MS Acquisition was pre-installed on your Agilent supplied

workstation at the factory, it will be in the Standard Workflow mode.

1. From the Control Panel, select

Programs and Features.

2. Select Agilent MassHunter GC/

MS Acquisition and click
Change.

3. Select Activate Compliance and

click next.

4. Follow the installer program

prompts to complete the process.

25
2. MassHunter GC/MS Acquisition - Setup and ConfigurationInstallation where MassHunter GC/MS Acquisition

Installation where NOTE: Details for installing MassHunter GC/MS Acquisition are included in the Agilent
MassHunter GC/MS MassHunter Workstation Offline Qualitative and Quantitative Analysis for GCMS
Installation Guide. The instructions here provide general guidance only. Please refer to the
Acquisition is installed in above document for complete installation details.
the User Management and
Audit Trail mode There are three general conditions under which you may be installing MassHunter GC/MS
Acquisition in Compliance mode. See the pages listed below for details on your particular
setup.
• The workstation has no previous version of MassHunter GC/MS Acquisition Installed
(page 24).
• The workstation has MassHunter GC/MS Acquisition installed in the Standard
Workflow mode (page 25).
• The workstation has MassHunter GC/MS Acquisition installed in the User Management
and Audit Trail mode (shown below, on this page) (page 26).

MassHunter GC/MS Acquisition Compliance cannot be activated on a workstation that

currently has MassHunter GC/MS Acquisition installed in the User Management and Audit
Trail mode.

To activate the Compliance mode,

uninstall the current version then,
insert the MassHunter GC/MS
Acquisition B.07.03 installation disk
and select Activate Compliance
during the re-installation procedure.

26
2. MassHunter GC/MS Acquisition - Setup and Configuration Configure an Instrument

Configure an Instrument After you have installed ECM on the server, downloaded ECM components to the
workstation, and installed MassHunter GC/MS Acquisition B.07.03 in Compliance mode,
you may configure one instrument.

1. Login to your workstation with

Windows Administrator
privileges.

2. Double-click the Configuration

Editor Icon.

3. Provide a valid user name and

password, and click Login.

4. Complete the configuration for

your instrument as applicable.
Notice that, because you have
installed MassHunter GC/MS
Acquisition in the Compliance
mode, the Regulated Workflow
Mode is selected in the
configuration editor. This cannot
be changed.

5. Click OK to complete the

configuration. Your configured
instrument may look similar to
this in the Configuration Editor.

27
2. MassHunter GC/MS Acquisition - Setup and Configuration Set the Password Reset Interval

Set the Password Reset To set or modify the interval required for users to reset their password:
Interval

1. In the Configuration Editor, select

Configure > Specify Secured
User Password Reset.

2. Enter the number of days after

which the password must be
changed, and press OK.

28
2. MassHunter GC/MS Acquisition - Setup and Configuration Set the Idle Timeout Interval

Set the Idle Timeout Interval Part of the requirements of FDA CFR21 Part 11 is that unattended workstations should
automatically lock. For MassHunter GC/MS Acquisition that timeout interval is set in the
Configuration Editor.

If MassHunter GC/MS Acquisition detects no activity from the current user for a specified
time, it will automatically lock the system and display the MassHunter GCMS Account
Login dialog.

Once MassHunter GC/MS Acquisition is locked, any user with a valid UserID and
Password may log into the system and unlock it. The menu items available are those
permitted to the user that unlocks MassHunter GC/MS Acquisition.

To modify the inactivity timeout interval:

1. In the Configuration Editor, select

Configure > Specify Idle
Timeout interval.

2. Enter the time, in minutes, you

wish to use for the idle timeout
interval, and press OK.

29
2. MassHunter GC/MS Acquisition - Setup and Configuration Set the Idle Timeout Interval

30
3
MassHunter GC/MS Acquisition -
Routine Tasks
Manually Lock and Switch Users 32
Review User Access Privileges 32
Understand ECM Storage Locations and File Types 33
Save and Retrieve Data, Methods, and Sequence Files 34
Change the ECM Storage Locations 35
Test the Communication with the ECM Server 36
View the Current LCDF path to the ECM Server 37
Open the ECM Server via Internet Explorer 38
Import a Method from a Location Outside the ECM Server 39

Chapter 3 describes routine tasks performed in MassHunter GC/MS Acquisition

in Compliance mode.
3. MassHunter GC/MS Acquisition - Routine Tasks Manually Lock and Switch Users

Manually Lock and Switch MassHunter GC/MS Acquisition defers the electronic signatures of records to an ECM
Users activity. Therefore, the operator doesn't have to sign every record. However, it is the
operator's responsibility to manually lock the MassHunter GC/MS Acquisition program
each time they walk away from the workstation.

1. To manually lock MassHunter

GC/MS Acquisition, click the
Lock and Switch User icon.

The system displays a login box with the cancel button disabled.

2. When a valid UserID and The only way to unlock MassHunter GC/MS Acquisition is to login with valid user
Password are entered, the credentials.
system resets the MassHunter
GC/MS Acquisition allowed
operations to those assigned to
the windows security group that
the logged in user is a member.

Review User Access When using MassHunter GC/MS Acquisition in the Compliance mode, menu options that
Privileges are displayed to each user are based on the user's access privileges. For MassHunter GC/
MS Acquisition, those privileges are control by the Windows security group to which they
are assigned.

See “MassHunter Acquisition Windows Security Groups” on page 73… for the default
settings of menu items available to each group.

See “Change Group Privileges” on page 79 for details on how to change these defaults.

32
3. MassHunter GC/MS Acquisition - Routine Tasks Understand ECM Storage Locations and File Types

Understand ECM Storage When using MassHunter GC/MS Acquisition in the Compliance mode, all regulated
Locations and File Types records are stored in ECM, with digital signatures being applied using ECM.

Default settings will look similar to this structure, however, your ECM administrator can
modify this as needed for your organization.
• L = Location, identifies the physical place where file cabinets are stored
• C = A file Cabinet
• D = Contains Drawers
• F = Inside the Drawers are Folders
• F = Inside the Folders are Files
Location
Cabinet
Drawer
Folder

Files saved to ECM from MassHunter GC/MS Acquisition may include the following files
types:
• Data (.D.SSIZIP)
• Method (.M.SSIZIP)
• Sequence (.XML.ZIP)
• Tune (.CSV)
• Air Water (.CSV)
• Tune Evaluation (.CSV)

Data files (.D.SSIZIP) include a zipped version of the data folder with all its contents
(including a audit-trail log file if one exists) in a single compressed file.

Method files (.M.SSIZIP) include all method components, including the method's
cumulative audit-trail log if one exists, in a single compressed file.

Sequence files (.XML.Zip) includes the sequence dataset file and the cumulative audit-trail
log file (if one exists) in a single compressed file.

33
3. MassHunter GC/MS Acquisition - Routine Tasks Save and Retrieve Data, Methods, and Sequence Files

Save and Retrieve Data,

Methods, and Sequence
Access to Method and Sequence files (while operating in the Compliance mode) is through
Files standard Load and Save menus. For example:
• To Load a Method, select Method > Load Method
• To Save a Method, select Method > Save Method
• To Save a Method as a different mane, select Method > Save Method As...

• To Load a Sequence, select Sequence > Load Sequence

• To Save a Sequence, select Sequence > Save Sequence
• To Save a Sequence as a different mane, select Sequence > Save Sequence As...

When data, methods, and sequences are stored in ECM, all the associated data is
packaged together in a single file with a SSIZIP extension.

This file type is a standard ZIP file and can be extracted with standard unzip applications.

When you save a file to ECM or retrieve a file from ECM the packaging and un-packaging of
the files is automatically handled for you.

34
3. MassHunter GC/MS Acquisition - Routine Tasks Change the ECM Storage Locations

Change the ECM Storage

Locations

1. Select ECM > Review/Change

ECM Preferences.

2. Select the folder you wish to

change, and click OK.

3. Modify the path as required and

click OK.

35
3. MassHunter GC/MS Acquisition - Routine Tasks Test the Communication with the ECM Server

Test the Communication The ECM diagnostic option allows you to check your connection to OpenLab ECM by
with the ECM Server uploading a test file to ECM and reporting the results in a dialog to you.

1. Select ECM > ECM Diagnostic.

2. At the prompt, enter the number

of times you wish to test the
connection (10, for example), and
click OK.

The system attempts to upload and download a test file the number of times specified (e.g.,
10 in this example), and reports the results of the test in a dialog.

3. Review the test results in the

bottom line of the instrument
control screen.

36
3. MassHunter GC/MS Acquisition - Routine Tasks View the Current LCDF path to the ECM Server

View the Current LCDF path

to the ECM Server

1. Select ECM > Report ECM

Configuration.

2. Review the path shown.

37
3. MassHunter GC/MS Acquisition - Routine Tasks Open the ECM Server via Internet Explorer

Open the ECM Server via

Internet Explorer

1. Select ECM > Run ECM

Explorer.

2. View the ECM server from

Internet Explorer.

38
3. MassHunter GC/MS Acquisition - Routine TasksImport a Method from a Location Outside the ECM Server

Import a Method from a

Location Outside the ECM
Server

1. Select Method > Import Method

components from another
method…

2. Navigate to and select the

desired file.

39
3. MassHunter GC/MS Acquisition - Routine TasksImport a Method from a Location Outside the ECM Server

40
4
MassHunter Quantitative Analysis -
Setup and Configuration
Review the Installation and Setup Steps 42
Installation where there was no previous version of MassHunter
Quantitative Analysis 43
Installation where MassHunter Quantitative Analysis B.07.01 is installed
in the Standard Workflow mode 44
Installation where MassHunter Quantitative Analysis B.07.01 is installed
in the User Management and Audit Trail mode 45
Installation where an older version of MassHunter Quantitative Analysis
is installed (pre B.07.01) 46
Associate ECM Roles to MassHunter Quantitative Analysis Command
Groups 47

Chapter 4 provides general guidance on how to install and set up MassHunter

Quantitative Analysis depending on which version is currently installed. It then
details how to associate ECM roles with MassHunter Quantitative Analysis
individual commands and command groups.
4. MassHunter Quantitative Analysis - Setup and Configuration Review the Installation and Setup Steps

Review the Installation and

Setup Steps

1. Verify the prerequisites. Before installing MassHunter Quantitative Analysis in ECM Compliance mode verify the
following:
• The LAN layout is supported by Agilent.
• You have local Windows workstation administrator credentials.
• The workstation is running Windows 7 Professional SP1 (64-bit) or Windows 10.
• The standalone ECM (3.4.1 SP2 or newer) server is operational.
• The ECM client is installed on the MassHunter workstation.

2. Select your installation type, and NOTE: The installation of MassHunter Quantitative Analysis is covered in detail in the
Install MassHunter Quantitative Agilent MassHunter Workstation Offline Qualitative and Quantitative Analysis for GCMS
Analysis. Installation Guide. Refer to that document for complete details. This section is intended to
provide general guidance only.

There are four general conditions under which you may be installing MassHunter
Quantitative Analysis in the Compliance mode. Each of these cases is described on the
pages indicated below:
• The Workstation has no previous installation of MassHunter Quantitative Analysis
(page 43)
• The Workstation has MassHunter Quantitative Analysis B.07.01 installed in Standard
Workflow mode. (page 44)
• The Workstation has MassHunter Quantitative Analysis B.07.01 installed in the User
Management and Audit Trail mode. (page 45)
• The Workstation has a version of MassHunter Quantitative Analysis that pre-dates
B.07.01. (page 46)

3. Associate ECM Roles with Before anyone can access MassHunter Quantitative Analysis:
MassHunter Quantitative
• They must have a valid ECM user account that is associated to an ECM role. (Refer to
Analysis Roles (Command
your ECM documentation for details on how to set up ECM user accounts).
Groups).
• ECM roles can contain MassHunter Quantitative Analysis commands. Quantitative
Analysis commands are associated with ECM roles in ECM or in the Quantitative
Analysis ATM Configuration program.

See “Associate ECM Roles to MassHunter Quantitative Analysis Command Groups” on

page 47 for details.

42
4. MassHunter Quantitative Analysis - Setup and ConfigurationInstallation where there was no previous version of

Installation where there NOTE: The installation of MassHunter Quantitative Analysis is covered in detail in the
was no previous version of Agilent MassHunter Workstation Offline Qualitative and Quantitative Analysis for GCMS
Installation Guide. Refer to that document for complete details. This section is intended to
MassHunter Quantitative provide general guidance only.
Analysis
There are four general conditions under which you may be installing MassHunter
Quantitative Analysis in the Compliance mode. Each of these cases is described on the
pages indicated below:
• The Workstation has no previous installation of MassHunter Quantitative Analysis
(shown below on this page) (page 43)
• The Workstation has MassHunter Quantitative Analysis B.07.01 installed in Standard
Workflow mode. (page 44)
• The Workstation has MassHunter Quantitative Analysis B.07.01 installed in the User
Management and Audit Trail mode. (page 45)
• The Workstation has a version of MassHunter Quantitative Analysis that pre-dates
B.07.01. (page 46)

If the Workstation has no previous version of MassHunter Quantitative Analysis

installed:

1. Insert the DVD and follow the

prompts to access this screen.

2. Select Activate Compliance, and

click Next to continue.

3. During the installation, you may

be prompted to install or update
some Windows components and
reboot your PC. After you reboot
and log in to your PC, the
Installation Wizard will proceed
to complete the installation of the
required Windows components.

4. If Report Templates were copied Report templates used must be from the same version of MassHunter Quantitative
to the workstation, upload them Analysis that is being used.
from the workstation to a
location in ECM that MassHunter Remember: Upload the report templates from your local drive to ECM.
Quantitative Analysis users will
be able to access.

43
4. MassHunter Quantitative Analysis - Setup and Configuration Installation where MassHunter Quantitative

Installation where NOTE: The installation of MassHunter Quantitative Analysis is covered in detail in the
MassHunter Quantitative Agilent MassHunter Workstation Offline Qualitative and Quantitative Analysis for GCMS
Installation Guide. Refer to that document for complete details. This section is intended to
Analysis B.07.01 is installed provide general guidance only.
in the Standard Workflow
mode There are four general conditions under which you may be installing MassHunter
Quantitative Analysis in the Compliance mode. Each of these cases is described on the
pages indicated below:
• The Workstation has no previous installation of MassHunter Quantitative Analysis
(page 43)
• The Workstation has MassHunter Quantitative Analysis B.07.01 installed in Standard
Workflow mode (shown below on this page). (page 44)
• The Workstation has MassHunter Quantitative Analysis B.07.01 installed in the User
Management and Audit Trail mode. (page 45)
• The Workstation has a version of MassHunter Quantitative Analysis that pre-dates
B.07.01. (page 46)

If MassHunter Quantitative Analysis B.07.01 is already installed on your workstation in the

Standard Workflow mode, you may use this procedure to activate the MassHunter
Compliance mode.

Note: If MassHunter Quantitative Analysis was pre-installed on your Agilent supplied

Workstation at the factory, it will be in the Standard Workflow mode.

1. Click Control Panel > Start and

enter Programs and Features.

2. Select Agilent MassHunter

Quantitative Analysis and click
Change.

3. Click Change.

4. Select Activate Compliance.

5. Continue to follow the prompts.

6. If Report Templates were copied

to the workstation, upload them
from the workstation to a
location in ECM that Quantitative
Analysis will have access.

44
4. MassHunter Quantitative Analysis - Setup and Configuration Installation where MassHunter Quantitative

Installation where NOTE: The installation of MassHunter Quantitative Analysis is covered in detail in the
MassHunter Quantitative Agilent MassHunter Workstation Offline Qualitative and Quantitative Analysis for GCMS
Installation Guide. Refer to that document for complete details. This section is intended to
Analysis B.07.01 is installed provide general guidance only.
in the User Management
and Audit Trail mode There are four general conditions under which you may be installing MassHunter
Quantitative Analysis in the Compliance mode. Each of these cases is described on the
pages indicated below:
• The Workstation has no previous installation of MassHunter Quantitative Analysis
(page 43)
• The Workstation has MassHunter Quantitative Analysis B.07.01 installed in Standard
Workflow mode. (page 44)
• The Workstation has MassHunter Quantitative Analysis B.07.01 installed in the User
Management and Audit Trail mode (shown below on this page). (page 45)
• The Workstation has a version of MassHunter Quantitative Analysis that pre-dates
B.07.01. (page 46)

MassHunter Compliance cannot be activated on a workstation that currently has

MassHunter Quantitative Analysis B.07.01 installed in the User Management and Audit
Trail mode. To activate the Compliance mode, uninstall the current version then, reinstall
version B.07.01 and select Activate Compliance during the installation procedure.

If Report Templates were copied to the workstation, upload them from the workstation to a
location in ECM that Quantitative Analysis will have access.

45
4. MassHunter Quantitative Analysis - Setup and ConfigurationInstallation where an older version of MassHunter

Installation where an older NOTE: The installation of MassHunter Quantitative Analysis is covered in detail in the
version of MassHunter Agilent MassHunter Workstation Offline Qualitative and Quantitative Analysis for GCMS
Installation Guide. Refer to that document for complete details. This section is intended to
Quantitative Analysis is provide general guidance only.
installed (pre B.07.01)
There are four general conditions under which you may be installing MassHunter
Quantitative Analysis in the Compliance mode. Each of these cases is described on the
pages indicated below:
• The Workstation has no previous installation of MassHunter Quantitative Analysis
(page 43)
• The Workstation has MassHunter Quantitative Analysis B.07.01 installed in Standard
Workflow mode. (page 44)
• The Workstation has MassHunter Quantitative Analysis B.07.01 installed in the User
Management and Audit Trail mode. (page 45)
• The Workstation has a version of MassHunter Quantitative Analysis that pre-dates
B.07.01 (shown below on this page). (page 46)

MassHunter Compliance is not supported in versions prior to B.07.01. If you have a version
of MassHunter Quantitative Analysis that is earlier than B.07.01, uninstall that version and
install version B.07.01 or higher, and select Activate Compliance when prompted during
installation.

If Report Templates were copied to the workstation, upload them from the workstation to a
location in ECM that Quantitative Analysis will have access.

46
4. MassHunter Quantitative Analysis - Setup and ConfigurationAssociate ECM Roles to MassHunter Quantitative

Associate ECM Roles to Access privileges for MassHunter Quantitative Analysis are controlled through the Audit
MassHunter Quantitative Trail Map (ATM) program. The following describes how to associate ECM roles to
MassHunter Quantitative Analysis roles using the Audit Trail Map (ATM) program.
Analysis Command Groups

1. Start the Audit Trail Map (ATM)

program.

2. Enter ECM system administrator

credentials.

3. Notice the four MassHunter

MassHunter Quantitative Analysis Roles
Quantitative Analysis Roles
(Command Groups) and ECM
roles.

See “Overview” on page 74 for a
complete listing of the
commands in each group.

ECM Roles

47
4. MassHunter Quantitative Analysis - Setup and ConfigurationAssociate ECM Roles to MassHunter Quantitative

4. Select the Batch Analysis Users assigned to this role may create a batch, review the results of a batch, integrate and
command group or select quantitate the results, and print batch reports.
individual commands under
Batch Analysis, and enable the
ECM roles that should be allowed
these privileges (e.g., Analyst and
Developer).

Click the arrow in front of Batch Analysis to display the full list of commands associated
with this role.

Click the arrow once again to return to the previous view.

48
4. MassHunter Quantitative Analysis - Setup and ConfigurationAssociate ECM Roles to MassHunter Quantitative

5. Select the Method Development Users assigned this role may run all the commands in the Method Development command
command group or select group. For example, they may create, modify, delete, and save methods.
individual commands under
Method Development, and
enable the ECM roles that should
be allowed these privileges (e.g.,
Developer).

6. Select the Batch Review Users assigned this role may open and review a batch.
command group or select
individual commands under
Batch Review, and enable the
ECM roles that should be allowed
these privileges (e.g., Analyst and
Developer).

7. Select the Report command Users assigned this role may generate reports.
group or select individual
commands under Report, and
enable the ECM roles that should
be allowed these privileges (e.g.,
Analyst and Developers).

8. Select File > Save to save your

changes before exiting ATM.

49
4. MassHunter Quantitative Analysis - Setup and ConfigurationAssociate ECM Roles to MassHunter Quantitative

50
5
MassHunter Quantitative Analysis -
Routine Tasks
Review User Access Privileges 52
Understand ECM Storage Locations and File Types 52
Access Files from Quantitative Analysis 53
Add Quantitative Analysis Report Templates to ECM 53

Chapter 5 describes routine tasks performed in MassHunter Quantitative

Analysis in Compliance mode.
5. MassHunter Quantitative Analysis - Routine Tasks Review User Access Privileges

Review User Access When using MassHunter Quantitative Analysis Compliance software, menu options that
Privileges are displayed to each user are based on the user's role assignment in ECM.

The ECM roles are then assigned to Quantitative Analysis individual commands or
command groups in the Quantitative Analysis ATM program. A Users privileges in the
Quantitative Analysis program are limited to the ATM command groups to which their ECM
role is assigned.

See “Associate ECM Roles to MassHunter Quantitative Analysis Command Groups” on

page 47 for details on changing privileges for a user in the Quantitative Analysis program.

Understand ECM Storage All regulated records are stored in ECM, with digital signatures being applied using ECM.
Locations and File Types
Default settings will look similar to this structure, however, your ECM administrator can
modify this as needed for your organization.
• L = Location, identifies the physical place where file cabinets are stored
• C = A file Cabinet
• D = Contains Drawers
• F = Inside the Drawers are Folders
• F = Inside the Folders are Files

Files saved to ECM may include the following files types:

• Data (.D.SSIZIP)
• Method (.M.SSIZIP, .quantmethod.xml)
• Batch (batch.bin.ssizip)
• Libraries (.L.SSIZIP, mslibrary.xml, reflibrary.xml)

Data files (.D.SSIZIP) include a zipped version of the data folder with all its contents
(including a audit-trail log file if one exists) in a single compressed file.

Method files (.M.SSIZIP, .quantmethod.xml) include all method components, including the
method's cumulative audit-trail log if one exists, in a single compressed file.

The .SSIZIP file type is a standard ZIP file and can be extracted with standard unzip
applications.

52
5. MassHunter Quantitative Analysis - Routine Tasks Access Files from Quantitative Analysis

Access Files from Access to files (while operating in Compliance) is through standard menus. For example:
Quantitative Analysis • To create a new Batch, select File > New Batch
• To Save a Batch, select File > Save Batch
• To generate a report, select File > Generate

When you save a file to ECM or retrieve a file from ECM the packaging and un-packaging of
the .SSIZIP files is automatically handled for you.

Add Quantitative Analysis

Report Templates to ECM

1. Open Internet Explorer and go to See your ECM administrator or the ECM Online help for information on the ECM privileges
the ECM URL. required to perform this procedure.

2. Create the LCDF structure To use report templates for Quantitative Analysis, users must have access to the ECM
required by your organization, location where the templates are stored.
such as the example shown here.
See “Associate ECM Roles to MassHunter Quantitative Analysis Command Groups” on
page 47 for details on changing privileges for a user in the Quantitative Analysis program

53
5. MassHunter Quantitative Analysis - Routine Tasks Add Quantitative Analysis Report Templates to ECM

3. Add the report templates to the See the ECM Online help for details on adding files including installing and using the Send
ECM folders. To > Agilent OpenLab ECM menu.

54
6
Audit Trails
GC/MS Acquisition - Enable/Disable Audit Reasons 56
GC/MS Acquisition - Edit the Pre-defined “Reason for Change” List 57
GC/MS Acquisition - View Instrument Audit Trail 58
GC/MS Acquisition - View and Print a Method Audit-Trail Log 58
GC/MS Acquisition - View and Print a Sequence Audit-Trail Log 59
GC/MS Acquisition - View and Print an Instrument Configuration Audit-
Trail Log 59

Quantitative Analysis - Audit Trail Overview 60

Quantitative Analysis - Generate an Audit Report 61
Quantitative Analysis - Enable/Disable Audit Reasons 63

Chapter 6 describes how to view or print audit-trail logs and how to enable or
disable the audit reasons shown in logs in both MassHunter GC/MS Acquisition
and Quantitative Analysis.
6. Audit Trails GC/MS Acquisition - Enable/Disable Audit Reasons

GC/MS Acquisition - Depending on how you configure MassHunter GC/MS Acquisition, each time a user
Enable/Disable Audit initiates an action which may result in modification to a sequence file, method file, or
instrument configuration, they may be prompted for a reason for that modification. The
Reasons reasons they enter are recorded in the audit-trail log.

With this feature enabled, when a user modifies a regulated record they will be prompted
for a reason for the change. The user may then:
• Select a reason from a pre-defined list of reasons. 
(There are three separate pre-defined lists; one for Methods, one for Sequences, and
one for Instrument Configurations.)
• Enter a custom reason as free-form text. The length of the free-form text will be limited
only by available system resources.

With this feature disabled, when a user modifies a regulated record, the date, time, and
user's name of the change is still recorded; however, the reason for the change (the
description column) is left blank.

To enable or disable this feature:

1. Access the Configuration Editor.

2. Select: Audit Trail > Enable/

Disable Audit Reasons.

56
6. Audit Trails GC/MS Acquisition - Edit the Pre-defined “Reason for Change” List

GC/MS Acquisition - If the Audit Reasons feature is enabled, when a user modifies a method, sequence, or
Edit the Pre-defined instrument configuration, he will be prompted for a reason for the change. He can then:
• Select a reason from a pre-defined list of reasons, or
“Reason for Change” List • Enter a custom reason as free-form text.

There are three separate pre-defined lists, one for:

• Method changes
• Sequence changes
• Instrument Configuration changes

To modify one of these pre-defined

lists:
1. In the Configuration Editor, select
Audit Trail > (Manage Method
Audit Reason lists), (Manage
Sequence Audit Reason lists),
or (Manage Instrument Audit
Reason Lists).

2. To edit or delete an item: a Select the pre-defined reason you want to edit or delete, and click Edit/Clear.
b Edit the pre-defined text or clear the text shown to delete the reason, and click OK.

3. To add a new item to the list: a Click New.

b Enter the text you want to show in the list of pre-defined reasons (for example,
changed oven ramp parameters), and click OK.

57
6. Audit Trails GC/MS Acquisition - View Instrument Audit Trail

GC/MS Acquisition -
View Instrument Audit Trail

To view a log of any edit made to the

instrument configuration, in the
Configuration Editor, select Audit
Trail > View Instrument Audit Trail.

GC/MS Acquisition - In MassHunter GC/MS Acquisition, select Method > View Method Audit-Trail Log.
View and Print a Method (Displays the Audit-Trail log for the currently loaded Method.)
Audit-Trail Log • To print the Summary Audit-Trail log, view the log, and then click Print.
• To print the Details Audit-Trail log, view the log, select Detailed Print, and then click
Print.
• To preview the log before printing, view the log, and then click Print Preview. This
displays a copy of the report in the Microsoft Report View, which you may review before
printing.

58
6. Audit Trails GC/MS Acquisition - View and Print a Sequence Audit-Trail Log

GC/MS Acquisition - In MassHunter GC/MS Acquisition, select Sequence > View Sequence Audit-Trail Log.
View and Print a Sequence (Displays the Audit-log for the currently loaded Sequence.)
Audit-Trail Log • To print the Summary Audit-Trail log, view the log, and then click Print.
• To print the Details Audit-Trail log, view the log, select Detailed Print, and then click
Print.
• To preview the log before printing, view the log, and then click Print Preview. This
displays a copy of the report in the Microsoft Report View, which you may review before
printing.

GC/MS Acquisition -
View and Print an
Instrument Configuration
Audit-Trail Log

In the Configuration Editor, select

AuditTrail > View Instrument Audit-
Trail. (Displays the log for each
configured instrument.)

• To print the Summary Audit-Trail log, view the log, and then click Print.
• To print the Details Audit-Trail log, view the log, select Detailed Print, and then click
Print.
• To preview the log before printing, view the log, and then click Print Preview. This
displays a copy of the report in the Microsoft Report View, which you may review before
printing.

59
6. Audit Trails Quantitative Analysis - Audit Trail Overview

Quantitative Analysis - MassHunter GC/MS Quantitative Analysis operating in the Compliance mode provides
Audit Trail Overview audit reports that include details of each time a Batch Analysis, Method Development,
Batch Review or Report command is used.

Additionally, as this mode is designed to support the requirements of the U.S. Food and
Drug Administration (FDA) regulations and the handling of electronic records and
electronic signatures published as 21 CFR Part 11, records are treated as regulated
records.

Based on the settings in the Audit Trail Management program (ATM), each time a user
issues a command in MassHunter Quantitative Analysis, they may be prompted to supply
one, or both, of the following:
• Supply a reason for the change
• Supply their valid user name and password

The information entered at the time they issue the command is included in the audit
reports.

60
6. Audit Trails Quantitative Analysis - Generate an Audit Report

Quantitative Analysis - Audit reports are generated in the same manner as all other reports in MassHunter
Generate an Audit Report Quantitative Analysis. Refer to your online Help for more details on generating reports. The
following is a brief summary of generating a batch audit trail report.

1. Select Report > Generate...

2. Click New to create a method

template for the Audit Trail
Report.

3. Click Add Template... . Navigate

to the location in ECM where you
saved your report templates, and
select, the report template you
wish to use. (For example,
AuditTrail.report.xml.)

61
6. Audit Trails Quantitative Analysis - Generate an Audit Report

4. Be sure to check the Audit Trail

box. If using the PDF report
template, you do not need to
check the Audit Trail box.

5. Click Save and Exit.

6. Click OK. The report is generated

to the destination listed.

62
6. Audit Trails Quantitative Analysis - Enable/Disable Audit Reasons

Quantitative Analysis - The Audit reason feature is enabled on an individual command basis.
Enable/Disable Audit
Reasons

To enable or disable this feature for a

command:

1. Start the Audit Trail Map (ATM).

2. Enter ECM system administrator

credentials.

3. There are four MassHunter

Quantitative Analysis Roles
(Command Groups).

Select the group to which the
command belongs. For example,
select the Batch Analysis group if
the command is a Batch Analysis
command.

MassHunter Roles ECM Roles

(Command Groups)

63
6. Audit Trails Quantitative Analysis - Enable/Disable Audit Reasons

4. Click the arrow in front of the

group name to display the full list
of commands associated with
this group.

64
6. Audit Trails Quantitative Analysis - Enable/Disable Audit Reasons

5. Select the command for which In this example the AddSample command is selected.
you want to activate the User
Validation and Reason feature.

6. Enable either one or both of the

validation requirements.

7. Select any additional commands

in this group and set their
validation requirements, as
desired.

8. Click the arrow once again to

return to the previous view and
repeat the process for commands
in another group, if desired.

9. When you are finished, select

File > Save to save the changes.

10. Now, when a user completes this If either one of the validation reasons was unchecked in ATM, it will be greyed out on this
command in MassHunter, they screen. If both “Required Command Reason” and “Requires User Validation” were checked
will be presented with a screen in ATM, both must be completed in MassHunter, as shown in this example.
similar to the following.

65
6. Audit Trails Quantitative Analysis - Enable/Disable Audit Reasons

66
7
MassHunter Quantitative Analysis
Command Groups
Overview 68
Batch Analysis Command Group 69
Method Development Command Group 70
Batch Review Command Group 71
Report Command Group 71

Chapter 7 provides a complete list of all the commands in each MassHunter

Quantitative Analysis command group: Batch Analysis, Method Development,
Batch Review, and Report.

See“Associate ECM Roles to MassHunter Quantitative Analysis Command

Groups” on page 47 for details on how to associate these to Quantitative
Analysis users.
7. MassHunter Quantitative Analysis Command Groups Overview

Overview Before using MassHutner Quantitative Analysis, each user must be assigned to an ECM
Role (listed in the right column of the ATM program).

Each ECM Role is associated with one or more MassHunter Quantitative Analysis
individual commands or command groups (shown in the left column of the ATM program).

There are four MassHunter Quantitative Analysis command groups in ATM:

• Batch Analysis
• Method Development
• Batch Review
• Report

The tasks a user may perform in MassHunter Quantitative Analysis are based on which
Command groups are associated with the ECM Role to which they are assigned. See
“Associate ECM Roles to MassHunter Quantitative Analysis Command Groups” on page 47
for details.

For example, here all users included in the System Administrator, Analysts, and Developer
ECM Roles, have access to the MassHunter Report commands.

MassHunter Roles ECM Roles

(Command Groups)

Each Command group is described below.

68
7. MassHunter Quantitative Analysis Command Groups Batch Analysis Command Group

Batch Analysis Command In the Batch Analysis command group there are commands used for routine batch analysis
Group tasks such as:
• Add or Remove samples
• Analyze, Calibrate, and Integrate the Batch
• Save

The complete list is shown below. Notice, in this example, only those users assigned to
either the Analysts or Developer group will have access to these commands in
MassHunter Quantitative Analysis.

69
7. MassHunter Quantitative Analysis Command Groups Method Development Command Group

Method Development In the Method Development command group there are commands used for routine method
Command Group development tasks such as Create, Import, and Save a new Method.
The complete list is shown below. Notice, in this example, only those users assigned to the
Developer group will have access to these commands in MassHunter Quantitative
Analysis.

70
7. MassHunter Quantitative Analysis Command Groups Batch Review Command Group

Batch Review Command In the Batch Review group there is a single command:
Group • OpenBatchTable

Notice, in this example, those users assigned to either the Analysts or Developer group
will be able to Open a Batch in MassHunter Quantitative Analysis.

Report Command Group In the Report group there are two commands:
• EditReportMethod
• Generate Report

Notice, in this example, those users assigned to the System Administrator, Analysts, and
Developer group will be able to use these commands in MassHunter Quantitative Analysis.

71
7. MassHunter Quantitative Analysis Command Groups Report Command Group

72
8
MassHunter Acquisition Windows
Security Groups
Overview 74
Sequence Menu 75
GC - Instrument Menu 75
MS - Instrument Menu 76
CTC/PAL - Instrument Menu 76
Miscellaneous Instrument Menu 77
View Menu 77
Batch Menu 78
Checkout Menu 78
Change Group Privileges 79

Chapter 8 provides a list of the default privileges assigned to the pre-defined

Windows security groups QuantAdministrators, QuantBatchAnalyzer,
QuantBatchReviewer, QuantMethodDeveloper, and Quant Report Generator, which
are used in MassHunter GC/MS Acquisition. The permissions are grouped by
their function.

The privileges each user has in MassHunter GC/MS Acquisition are based on
the Windows security group to which they have been assigned. After you have
reviewed the roles and responsibilities associated with these groups, assign
each MassHunter GC/MS Acquisition user to one of the groups. See “Assign
Users to a Windows security group” on page 22
8. MassHunter Acquisition Windows Security Groups Overview

Overview The privileges each user has in MassHunter GC/MS Acquisition are based on the
Windows security group to which they have been assigned. After you have reviewed the
roles and responsibilities associated with these groups, assign each MassHunter GC/MS
Acquisition user to one of the groups. See “Assign Users to a Windows security group” on
page 22

Method Menu Default privileges to entries under the Method menu and Method icons are listed in the
following table. See “Change Group Privileges” on page 79 for details on how to change
these settings.

Analyst Analyst Analyst 

Method Menus and Icons I II III Manager

Additional method information    

Load Method    
Run Method    
RTL – Acquire RTL Calibration Data   
RTL – Unlock Method or Relock Method   
Edit Entire Method  
Edit Method Information  
Print Method  
Save or Save As Method  
Intelligent Sequence   
Parameters – Edit or Print
Use Classic DA menu  
Edit Intelligent Sequence Parameters  
Edit Method  
Set Default Paths 
View Method Audit Trail 
Zip/Unzip Method and Data 

74
8. MassHunter Acquisition Windows Security Groups Sequence Menu

Sequence Menu Default privileges to entries under the Sequence menu and icons are listed in the following
table. See “Change Group Privileges” on page 79 for details on how to change these
settings.

Sequence Menus and Icons Analyst I Analyst II Analyst III Manager

Simulate Sequence    
Load Sequence    
Run Sequence    
Save Sequence   
View Sequence Log   
View Sequence Quality Log   
Edit Sequence   
Position and Run Sequence   
Print Sequence Log   
Save Sequence As  
Additional Sequence Options  

GC - Instrument Menu Default privileges to entries under the GC segment of the Instrument menu and icons are
listed in the following table. See “Change Group Privileges” on page 79 for details on how
to change these settings.

GC - Instrument     
Menus and Icons Analyst I Analyst II Analyst III Manager
GC Show/Hide Status    
GC Sleep    
GC Wake    
GC Parameters  
GC Real Time Plots  
GC Sample Prep  
GC Configuration 

75
8. MassHunter Acquisition Windows Security Groups MS - Instrument Menu

MS - Instrument Menu Default privileges to entries under the MS segment of the Instrument menu and icons are
listed in the following table. See “Change Group Privileges” on page 79 for details on how
to change these settings.

MS - Instrument     
Menus and Icons Analyst I Analyst II Analyst III Manager
MS Vacuum Control   
MS Tune File   
MS CI Control  
Tune MSD  
Edit Tune Parameters  
MS Edit Parameters  
MS Temperatures  
Configure MS Source  
Select MS Tune File  
MS Status Panel
Apply button  
Edit button  
Override button  

CTC/PAL - Instrument Default privileges for access to entries under the CTC/PAL segment of the Instrument
Menu menu and icons are listed in the following table. See “Change Group Privileges” on page 79
for details on how to change these settings.

CTC/PAL Instrument     
Menus and Icons Analyst I Analyst II Analyst III Manager
Change Configuration 
Configuration 
Edit Cycles  
Edit Method  
Import Cycles  
Parameters  

76
8. MassHunter Acquisition Windows Security Groups Miscellaneous Instrument Menu

Miscellaneous Instrument Default privileges to miscellaneous entries under the Instrument menu and icons are listed
Menu in the following table. See “Change Group Privileges” on page 79 for details on how to
change these settings.

Miscellaneous Items on the    

Instrument Menu and Icons Analyst I Analyst II Analyst III Manager
Switch Filament   
ALS Parameters  
Backflush Wizard  
HeadSpace Parameters  
Inlet/Injection types  
Edit Monitors  
QTOF MassCal  
HeadSpace Parameters 

View Menu Default privileges to entries under the View menu and icons are listed in the following
table. See “Change Group Privileges” on page 79 for details on how to change these
settings.

View Menus and Icons Analyst I Analyst II Analyst III Manager

Data Analysis    
Instrument Control    
Arrange Monitors    
Chromatogram    
Save Layout    
Spectrum    
Tile Horizontal    
Tune and Vacuum Control  

77
8. MassHunter Acquisition Windows Security Groups Batch Menu

Batch Menu Default privileges for access to entries under the Batch menu and icons are listed in the
following table. See “Change Group Privileges” on page 79 for details on how to change
these settings.

Batch Menu and Icons Analyst I Analyst II Analyst III Manager

Run Batch    
Load and Run Batch    
Load Batch    
Set Up and Run Batch – short menu    
Simulate Batch    
Position and Run Batch   
Print Batch   
Print Batch Log   
Print Post-Batch Sequence Table   
Print Pre-Batch Sequence Table   
View Batch Log   
Save Batch   
Edit Batch   
Select Post Batch Reports  
More Batch  

Checkout Menu Default privileges to entries under the Checkout menu and icons are listed in the following
table. See “Change Group Privileges” on page 79 for details on how to change these
settings.

Checkout Menu and Icons Analyst I Analyst II Analyst III Manager

Evaluate Tune    
High Mass Check    
Sensitivity Check    
Checkout Tune    
View Previous Tunes…    

78
8. MassHunter Acquisition Windows Security Groups Change Group Privileges

Change Group Privileges During installation, MassHunter GC/MS Acquisition created four Windows security
groups.
• Manager (The highest level of privileges)
• Acquisition Analysts III
• Acquisition Analysts II
• Acquisition Analysts I (The lowest level of privileges)

To change these settings:

1. Login to your workstation with

Windows Administrator
privileges.

2. Double-click Configuration
Editor.

3. Provide a valid user name and

password, and click Login.

4. In the Configuration Editor, select

Configure > Manage Roles and
Responsibilities.

79
8. MassHunter Acquisition Windows Security Groups Change Group Privileges

5. Click the column heading to sort

the list by Description, and locate
the responsibility you want to
change.

6. In the Responsibility column,

select the item you want to
modify, Method load menu, for
example.

7. Double click the corresponding

entry in the Role column to
display a drop-down selection
list.

8. Select the new Minimum Role For example, you could change the Load Method menu:
you want to use for this
• From a minimum role requirement of Analyst I
Responsibility.
• To a minimum role requirement of Analyst II

80
9
Supported Network Topologies for
Compliance Security Mode
Single GC/MS Workstation (Acquisition PC) 82
GC/MS Workstation (Acquisition PC) Plus a Data Review Station
(Review PC) 82
GC/MS Workstation (Acquisition PC) Plus Data Processing (Process PC)
Plus Data Review (Review PC) 83
Scaled Network Solution Multiple GC/MS Systems 83
Scaled Network Solution Multiple GC/MS Systems + Multiple
Processing and Review Stations 84

Chapter 9 includes examples of the network configurations supported by

MassHunter compliance mode.

All supported configurations require an ECM server installation of version 

3.4.1 SP2 or greater.
9. Supported Network Topologies for Compliance Security ModeSingle GC/MS Workstation (Acquisition PC)

Single GC/MS Workstation • Data is acquired, processed, reviewed and approved on a single GC/MS Workstation
(Acquisition PC) (Acquisition PC).
• Data and Results are secured using OpenLab ECM Server.

GC/MS Acquisition
ECM Server
Instrument PC
Collect Secure
Data Data
Process
Data
Approve
Results

GC/MS Workstation • Data is collected and processed on a GC/MS Workstation (Acquisition PC).
(Acquisition PC) Plus a • All data is secured using OpenLab ECM Server.
Data Review Station • Results are reprocessed and approved on a second PC (Review PC).
(Review PC)
GC/MS Acquisition Review
ECM Server
Instrument PC PC
Collect Secure Reprocess
Data Data Data
Process Approve
Data Results

82
9. Supported Network Topologies for Compliance Security ModeGC/MS Workstation (Acquisition PC) Plus Data

GC/MS Workstation • Data is collected and processed on a GC/MS Workstation (Acquisition PC).
(Acquisition PC) Plus Data • All data is secured using OpenLab ECM Server.
Processing (Process PC) • Results can be reprocessed and approved on a separate PC (Process PC).
Plus Data Review (Review • Results can also be reviewed on an additional PC (Review PC).
PC)
GC/MS Acquisition Process
ECM Server
Instrument PC PC
Collect Secure Process
Data Data Data

Review
PC
Review
Data

Scaled Network Solution • A Lab acquires, processes, reviews, and approves data from a single instrument on a
Multiple GC/MS Systems single PC, as illustrated in the brackets below.
• Data and Results from multiple instruments are secured using OpenLab ECM Server.
Therefore, a lab could have multiple versions of what is in the brackets, all going in to
the same OpenLab ECM server.

GC/MS Acquisition
ECM Server
Instrument PC
Collect Secure
Data Data
Process
Data
Approve
Results
n × GC/MS

83
9. Supported Network Topologies for Compliance Security Mode Scaled Network Solution Multiple GC/MS

Scaled Network Solution • A lab collects and processes data on one acquisition PC.
Multiple GC/MS Systems + • Results from any instrument can be reprocessed and reviewed from alternate PCs.
Multiple Processing and • All data is secured using OpenLab ECM Server.
Review Stations
GC/MS Acquisition Review
ECM Server
Instrument PC PC
Collect Secure Reprocess
Data Data Data
Process Approve
Data Results

n × GC/MS m × Review PCs

84
Agilent Technologies

© Agilent Technologies, Inc.

Printed in USA, November 2018
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