Empower Data Integrity:

Self Assessment to Prepare for Internal or

External Questions

Presented by:
Mr. Jose Wilson Castro
jose_wilson_castro@waters.com

©2016 Waters Corporation 1

 Disclaimer

This presentation is for informational purposes only and should

not be taken as advice regarding any particular course of action
to be followed.
Waters does not make any representations or warranties,
express or implied, to any party, regarding use of the
information contained in this presentation to make decisions
regarding the implementation and maintenance of effective
quality control systems and quality assurance testing programs,
including but not limited to the applicable Good Manufacturing
Regulations that apply to the manufacture of regulated
products.

©2016 Waters Corporation 2

 Company Concerns and Culture

General Concerns

• Data Review
• Audit Trail Review
• Multiple Results
• Orphan Data
• Periodic Evaluation & Incident Management
• Historical Data

Summary

©2016 Waters Corporation 3

 Company Concerns and Culture

General Concerns

• Audit Trail Review

• Data Review
• Multiple Results
• Orphan Data
• Periodic Evaluation & Incident Management
• Historical Data

Summary

©2016 Waters Corporation 4

 New Definitions of Data Integrity

MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/412735/Data_integrity_definitions_and_guidance_v2.pdf

©2016 Waters Corporation 5

 New Definitions of Data Integrity

World Health Organization Guidance on Good Data and Record Management Practices September 2015
http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidance-on-good-data-management-practices_QAS15-
624_16092015.pdf

©2016 Waters Corporation 6

 ALCOA +

Attributable: who acquired the data or performed an action?

Legible: can you read and understand the data entries?
Contemporaneous: documented at the time of the activity
Original: first recorded observation
Accurate: no errors or editing?
+
Complete — all data including any repeat or reanalysis performed

Consistent — all elements of the analysis, such as the sequence of events,

follow on and are dated or time stamped in expected sequence

Enduring — recorded in a permanent, maintainable form for the useful life

Available — for review and audit or inspection over the lifetime of the record
7
©2016 Waters Corporation 7
 Why is Data Integrity so important?
No
Strength Validation or
Change
Control

Quality Identity Sharing Delete

Accounts Privileges

Unsecured No Audit
Data Trail
D Safety
Purity
Data
Loss of confidence/trustAin the Manipulation
company Regulatory
T
Question all processes and Inspector
Review
procedures Poor OOS of
Aproduct
Question the safety of the
lab errors

All data:
Poor Review
good and
of Data
bad
©2016 Waters Corporation 8
 Benefits of Computerized Systems for
Data Integrity

Electronic
Records
Printed
Records

Written Data integrity is NOT a new

problem, more control /
Records documentation can be
implemented with
computerized systems

©2016 Waters Corporation 9

There is SO MUCH INFORMATION how
do you know where to start?
Consistent review and oversight is key
– Notice areas of concern and evaluate system and procedural controls
– Proactive controls verses retroactive forensic investigation
Educate and empower employees
– Company culture is very important
Evaluate what is feasible for your company
– What are your highest RISKS
o Patient and company
– What are your constraints with personnel time and company funds?
– What can you implement at you company now? and in the future?
– What processes are practical for your business?
o Be compliant with your own SOPs, do not implement procedures
and policies that cannot be reasonably performed

©2016 Waters Corporation 10

 Company Culture is Important

It is important to find a balance between compliance and

business goals because both are important
– Don’t inadvertently tempt individuals to try and avoid compliance
because the compliant path is hard and complex

Business Compliance Business Compliance

©2016 Waters Corporation 11

 Company Concerns and Culture

General Concerns

• Data Review
• Audit Trail Review
• Multiple Results
• Orphan Data
• Periodic Evaluation & Incident Management
• Historical Data

Summary

©2016 Waters Corporation 12

 Paper Does Not Always Provide the
Complete Story

COMPLEX
Printouts are NOT
Representative

LIMS
HPLC,
GC
UV
SIMPLE
Printouts
Spec
COULD
represent
original
pH
data Meter
Picture is a rendition of the image found in the MHRA GMP Data Integrity Definitions and
Guidance for Industry (March 2015)
©2016 Waters Corporation 13
 Problem 1: How Do I Perform Regular
Review

I don’t work in the laboratory and so my knowledge of the

Chromatography Data System is minimal. Do I really have to
learn this WHOLE system to review the data? Can’t I just get a
printed out report and have that be sufficient?

©2016 Waters Corporation 14

Empower: Data and Metadata is Linked

Sample Standards Used

Sets for Calibration

Original Calibration
Processing Method Curves

Unchanged
Raw Data
File
Unique
Result
Original
Instrument Method

Who Collected, Processed

Reviewed, Approved?
Product Code/ When, What, Why?
E-Cord Information Stage Reagent
LIMS ID
LC/GC System Used

©2016 Waters Corporation 15

 Data Review SOP suggestions

Should be performed on ELECTRONIC data in the application at

least at Peer Review level
– Not relying on paper /pdf or Empower reports entirely
Define a Process
– Start at either the end result and work backwards to acquisition
– Or start at acquisition and work towards the result
Look at final results (summaries, averages, CofA)
– Work back through the data from final quantitation, to areas and
integration to SampleSet meta data to audit trails
– Specifically focus on suspect data
o Define a list of warning signs..
• Integration / multiple results / metadata changes
• Results that only just meet specification

©2016 Waters Corporation 16

Result Audit Viewer Tool

One Stop Solution:

• Project Audit Trails

• Method History and Differences
• Sample History
• Sample Set History
• Acquisition Log
• Injection Log New in Feature Release 2
©2016 Waters Corporation 17
Result Audit Viewer Tool

Update for Your Needs:

• Table properties can be updated

to show important parameters for
your review

©2016 Waters Corporation 18

 Real Life Scenario…What is the Wider
Impact?

Let’s go into Empower and perform a

review
FDA Warning Letter Statement:
The analysis fails system suitability “your response does not
requirements. OOS documentation is adequately address the impact
created and the failing analysis is of the effect ”
determined to be caused by the column by
why? What is the root cause?

During a routine internal audit one of the FDA Warning Letter Statement:
mobile phases used for analysis is noticed “you did not perform a
to have had the wrong expiration date comprehensive investigation and
assigned to it, two weeks beyond its actual
a retrospective review”
expiration. Was it used past expiration?
What analysis were performed using this
mobile phase? Was it used to release
product?

©2016 Waters Corporation 19

 Real Life Solution…

Let’s talk about What LABORATORY ANALYTICS IS…and then

how it can solve some of your concerns.

In this situation we have a dashboard to address this concern

Keyword Analysis Dashboard

– Custom Field
– Sample Set Name
– Sample Name
– Project Name

©2016 Waters Corporation 20

 “Data Integrity Dashboard”
– Keyword Analysis
Provides the ability to search using key words, with respect to Sample set name, sample
name, project name, and custom field values.

This column was used

multiple times for
another project,
different mobile phases
and product

©2016 Waters Corporation 21

 Company Concerns and Culture

General Concerns

• Data Review
• Audit Trail Review
• Multiple Results
• Orphan Data
• Periodic Evaluation & Incident Management
• Historical Data

Other Tools

©2016 Waters Corporation 22

 Problem 2: Audit Trail Review

REGULARLY REVIEWED
MHRA guidance for Data Integrity states that organizations

“not expected to implement a forensic approach to data checking on

a routine basis, ….”

http://ec.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_en.pdf

©2016 Waters Corporation 23

 How to document Data Review
including Audit Trails

Review chromatograms, methods and relevant Audit Trails in

Empower application
Document that process by SIGNATURE
– Sign a report to document that you have followed the review SOP

I sign this data to attest that I performed/ reviewed / approved this

data according to SOP 12345

SOP should document what to review and how it should be done by

your role

Similar to other laboratory tasks where there is no proof of the

activity (such as making mobile phases or sample preparation)
other than a user attesting to their completion of the task

©2016 Waters Corporation 24

Real Life Scenario…What is the Wider
Impact?
Go into Empower – review audit trail
and find updates to processing method
and manual integrations are performed
frequently….WHY?

Regular review provided insight to look FDA Warning Letter

into a previously unnoticed concern. Is Statement:
this a problem or a one time “comprehensive
occurrence? assessment of the extent
of your practice”
High level overview to look at Method
Robustness where you can see the
number of versions and how often
manual results created?
o Is the analytical method robust?
(important during development, tech
transfer, and QC activities)
o Is it a training issue?
o Is there a concern with users trying to
manipulate data to pass?

©2016 Waters Corporation 25

 Do You Measure
Processing Method Robustness?
Examining the number of re-processes, and the % of
manual processing gives an indication of method robustness

Some methods show

100% manual
processing.

©2016 Waters Corporation 26

 Do You Know the Number of Versions
for Each method…and Why?
Examining a method summary listing number of versions
could identify compliance concerns

©2016 Waters Corporation 27

 Company Concerns and Culture

General Concerns

• Data Review
• Audit Trail Review
• Multiple Results
• Orphan Data
• Periodic Evaluation & Incident Management
• Historical Data

Other Tools

©2016 Waters Corporation 28

 Problem 3: Multiple Results

Result
Result(1)
Set

Result(2)
Sample Result
Set Set
Result(3)

Channel Result(4)

Outlining the process in a SOP can provide a clear UNDERSTANDING for

users, reviewers, and auditors

Data review is more effective with an outlined process and determine if

there is a problem
©2016 Waters Corporation 29
 Acquisition/Processing Results SOP:

Make life simple: always process for Result Sets

– Keeps all results together with a common identifier
– Easier to understand the story of what happened
– Makes it easier to identify results not addressed or reported

Don’t force “right first time” integration rules

– Remember processes should be aligned with the business

Include example of what integration should look like

– Don’t specify “parameters” specify “outcome”
– Clearly define when manual integration is permitted

©2016 Waters Corporation 30

How do I know what to review?

Version 1: Version 36:

Fail Criteria Pass Criteria

©2016 Waters Corporation 31

Reviewing and Signing all Results..
Even rejected results?

Right click > Report Viewer

©2016 Waters Corporation 32

 View Filters: Oversight for
What You Need to Know?

©2016 Waters Corporation 33

 Real Life Scenario…What is the Wider
Impact?
FDA Warning Letter Statement:
“provide a corrective action plan
for investigating the extent of this
deficiency”

Once you implement a CAPA you

may have to perform an
assessment once complete. How
do you know the CAPA solved the
problem?

FDA Warning Letter Statement:

“you did not perform a
comprehensive investigation and
a retrospective review to
ascertain the extent of this data
alteration practice”
©2016 Waters Corporation 34
Oversight of the Laboratory
Workflow

Number of Days to
Sign-Off
34 vs 7 days

©2016 Waters Corporation 35

 Company Concerns and Culture

General Concerns

• Data Review
• Audit Trail Review
• Multiple Results
• Orphan Data
• Periodic Evaluation & Incident Management
• Historical Data

Other Tools

©2016 Waters Corporation 36

 Problem 4: Orphan Data

Data is
Result(3)
Result Reported
Sets
Sample Result(2)
Project A Set
Result
Result(1)
Set

A well defined SOP for processing will help, but does that
project show all the data?

Data is not
Initial
Project B Sample Set
Result Sets Result(1) reported or
addressed

Technical controls (project access and project creation) are

important
©2016 Waters Corporation 37
 Project /Folder controls

Designing how projects or folders can be

used is essential
– Only created by trained users/administrators
o Restrict access to only required personnel
– Contain all methods and calculations required
for a specific test
– Ensures that ALL data can be easily located
o Controls user behavior to put data in the right
place
o Assures reviewers that no data is “missing”
• In the live CDS
• In archives

©2016 Waters Corporation 38

 Real Life Scenario…What is the Wider
Impact?

FDA Warning Letter Statement:

“did not include a comprehensive
review of all records”

You perform your regular review

and notice there is a result set that
has not been signed off. This is
against procedure. Is this isolated
to this one instance?

FDA Warning Letter Statement:

“describe the actions you have
taken or will take to prevent the
recurrence of CGMP violations,
including breaches of data
integrity”

©2016 Waters Corporation 39

 Laboratory Analytics can do the
following (Data Integrity Dashboard):

Check other projects for

– Single injections
– Sample sets from a single vial
– Unprocessed channels
– Injection/sample set abort activity
– Multiple injections of the same sample – sample name is the same

User Account Details

– How many user groups have access – are their any projects that
are owner only that no one can see

©2016 Waters Corporation 40

 “Data Integrity Dashboard”
– Single Injection Details
Provides the ability to
Identify a list of injections/samples that are not associated to a sample set.
Filtered by Node, Year and Month (Year is a required filter)
View associated information, including custom field information

Locates injections not

associated with a
sample set

©2016 Waters Corporation 41

 “Data Integrity Dashboard”
– Unprocessed Injections

Provides the ability to:

Identify a list of Injections/channels that have not been processed
Filter by Node, Project name, date range
Specific channels can be excluded (Channel NOT filter. E.g. Pressure, Temperature etc)
Sample sets which have not been processed can be highlighted and investigated

Unprocessed results
from all projects
©2016 Waters Corporation 42
“Data Integrity Dashboard”
–Injections, Sample Sets, Unprocessed
channels filtered by Sample Name

Identify injections, sample sets and channels referencing a given Sample Name
useful during investigations; sample, instrument, user, date range
multiple filters available to minimise scope, e.g. Project, System, Sample Set name/id,
user, vial etc

The same Sample Name

is in both Sample Sets.

©2016 Waters Corporation 43

 Company Concerns and Culture

General Concerns

• Data Review
• Audit Trail Review
• Multiple Results
• Orphan Data
• Periodic Evaluation & Incident Management
• Historical Data

Summary

©2016 Waters Corporation 44

 Problem 5: Periodic Evaluation &
Incident Management

http://ec.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_en.pdf

©2016 Waters Corporation 45

How quickly can you find the error?

©2016 Waters Corporation 46

 Periodic Review

It’s like an internal audit on the compliance of the system

– Find concerns BEFORE the audit
– Find ways to improve the efficiency of systems and processes
– documented evidence of actively searching for data integrity issues

A formal report must be written about the review

– It is a regulatory requirement

How often should I perform periodic review?

– This is a company decision and may depend on the criticality and maturity of the
system (3-24 months)

Periodic Review should determine if the system is still in a validated state

– Review major and minor changes to determine if any retesting or additional testing
of new functionality is required
– Review system audit trails for correct use of administrator functionalities

©2016 Waters Corporation 47

 Real Life Scenario…What is the Wider
Impact?

FDA Warning Letter Statement:

“Include a detailed action plan ”

I want to perform an assessment to ensure that

individuals are adhering to the newly implemented
procedures. I want to perform my assessment
based upon risk, what projects should I review?

FDA Warning Letter Statement:

“comprehensive assessment of
the extent of your practice”

©2016 Waters Corporation 48

 What can Laboratory Analytics do to
help?

Top 10 Users by Node – Injections per project you can use this
dashboard to focus on where you want to perform a spot checks
for adherence to SOP procedures

Do you want to
audit a frequent or
infrequent user?

©2016 Waters Corporation 49

 What can Laboratory Analytics do to
help?

Method periodic review using Summary by User application and

message center dashboard
– Provide an overview of potential problems to determine if there are
any underlying concerns that are common/widespread

User has not been

trained on this
method but has
run 28 injections.

©2016 Waters Corporation 50

 Company Concerns and Culture

General Concerns

• Data Review
• Audit Trail Review
• Multiple Results
• Orphan Data
• Periodic Evaluation & Incident Management
• Historical Data

Summary

©2016 Waters Corporation 51

 Problem 6: What About Previous
Data?

A solid plan for the future is well

determined but what about all my
old data…..?
3-5
YEARS
1
YEAR

6
MONTHS

NOW

?
©2016 Waters Corporation 52
 Waters Laboratory Analytics gets you
a step ahead…

The ability to data mine ALL of your data using the same tools
and dashboards so you can perform a quick assessment on if
CAPA initiatives, Lean/Six Sigma implementations, or process
improvements had an impact

FDA Warning Letter Statement:

FDA Warning Letter Statement: “However, your response still
“Also provide a list of all the lacks a comprehensive
batches of drug products assessment and retrospective
shipped to the U.S. market and review of data generated from
APIs intended for use in drugs to all of your computerized
be distributed within the U.S. laboratory systems. This
that relied upon missing, includes but is not limited to a
inaccurate, or unreliable risk assessment that evaluates
records.” all potentially-affected test
data.”

©2016 Waters Corporation 53

 Company Concerns and Culture

General Concerns

• Data Review
• Audit Trail Review
• Multiple Results
• Orphan Data
• Periodic Evaluation & Incident Management
• Historical Data

Summary

©2016 Waters Corporation 54

 Empower Laboratory Analytics:
Search Data

Laboratory analytics does NOT replace day-to-day review but ENHANCES

oversight and capabilities

Most metadata extracted from Empower :

– Sample Sets, Vials, Injections, Channels, Results & Sign Offs
– Custom Field data
– Users / Groups / User types
– System Audit Trails
– Project Audit Trails

Data extracted and re-modelled into a structure more conducive to

searching across many projects & millions of rows of data.

Filters can be used to pinpoint data / records of interest

©2016 Waters Corporation 55

 Waters Laboratory Analytics for
Laboratory Operations Review
Data Integrity Dashboard is new and covers:

Single Injections (Injections without a Sample Set ID)

Unprocessed Channels
Unlocked Channels
Unsigned Results
Deletion activity
Multiple Injections of the same Sample

Laboratory Analytics comes with more dashboards that cover…

– Lab Overview – System Usage Patterns - GMT

– Projects – Message Center
– Top Messages
– System Usage- Date
– Message Details
– System Usage- Date- Days used
– Users
– System Usage Local – Score Card
– System Usage Patterns – Local • Overview
• Improve Lab Workflow
– System Usage Method/User
• Increase System Utilization
– System Usage GMT • Manage Message Center

©2016 Waters Corporation 56

 Additional Resources

Waters eLearning-On-Demand
(course availability may vary by region)
http://www.waters.com/waters/en_US/eLearning-On-Demand-Courses/nav.htm?cid=134780935

– Empower 3: Reviewing Data Electronically Track

– Empower 3 in a Regulated Lab eLearning Track
– Empower 3 FR2 Advanced Topics : Reviewing Results
– Empower 3 Pro Fundamentals - Reviewing Results
– Empower 3 Regulated Lab - Data Management
– Empower 3 Regulated Lab - Data Security
– Empower 3 Regulated Lab - Empower Access
– Empower 3 Regulated Lab - Project Audit Trail
– Empower 3 Regulated Lab - System Audit Trail
– Empower 3 Regulated Lab- Electronic Sign Off
– Empower 3: Reviewing Data Electronically-System Policies
– Empower 3: Reviewing Data Electronically-User Management
– ….. and many more

©2016 Waters Corporation 57

 Waters Informatics Services

Project Management

Implementation Support

Architecture and Infrastructure

Software Installation & Configuration

Instrument/Software Qualification

Computer Systems Validation Services

Training Services

Integration Services

Empower Consultation Services

©2016 Waters Corporation 58

 Detailed Information

©2016 Waters Corporation 59

 PLANNING Stage

User Requirement Specification Validation Plan (VP)

(URS) An overview of the entire project
How YOU will use the system The activities to be done to meet
within your laboratory the regulations that YOU work
What you want from the system within
Defines the critical requirements: How they will be performed and
– Security, data integrity who is responsible
– Differential access of roles What are the requirements for
– Global policies configured in the system acceptance
application – “fit for intended use”
– Data Acquisition, Processing, How the system will be
Reporting
maintained in a compliant state
– Recovery of system during an
for the duration of its use?
interruption in network or
– throughout its operating life
database connectivity

©2016 Waters Corporation 60

 SPECIFICATION Stage

Risk Assessment (RA)

The Risk Assessment documents the risk priority determined for each function
from the URS
The risk priority is determined by a combination of severity of harm, likelihood
of occurrence and probability of detection
It is very important to clearly define the scope of the risk assessment
– What is in scope e.g. system limits and functionality
– What is out of scope e.g. IT infrastructure, other interfacing systems e.g. SAP, LIMS

Configuration Specification (CS) Test Plan (TP)

HOW the supplier product has been It is a review of functions by risk
configured to meet your specific priority against standard testing
needs, and to mitigate identified risks It will identify functions where
It is essential to provide a record of additional testing (above the
what has been installed and standard testing) may be justified
configured at your site.

©2016 Waters Corporation 61

 CONFIGURATION Stage

Two elements to configuration:

Applying system licences to activate optional modules
– System suitability
– Dissolution
– Instrument control software
– Method Validation Manager, etc.
– Generally done immediately after automated IQ/OQ has completed.

Applying the settings from the Configuration Specification to the

installed system
– System policies
– User types
– Password controls
– Often done as the first test protocol of the Performance Qualification

©2016 Waters Corporation 62

 VERIFICATION Stage:
Key Considerations

As a networked system, after qualification it

can be assumed that all processing clients are
IDENTICAL.
Any further verification testing can be done on a single client
– the results are valid for all clients.
What additional functions are tested depends on the outcome of
the RISK ASSESSMENT:
– High risk functions must be tested in the positive and negative case
– Medium risk functions must be tested at normal operating conditions
– Low risk functions may not be tested

Adding further clients in the future only needs the Qualification

activities and an update to the system configuration listing.

©2016 Waters Corporation 63

 VERIFICATION Stage:
Risk-Based Testing

Customized OQ Performance Qualification (PQ)

To test the limits and To verify that the user
boundaries of high risk priority configuration provides a system
functions (critical functions), such that is fit for intended use,
as: including (but not limited to):
– Password is valid until expiry and – Configuration has been
grants access during that time implemented according to CS
– After expiry, password does not give – Server is physically and logically
you access to the system secured
– New password must meet – User configured backup runs
complexity requirements correctly and creates a functional
To ensure medium risk priority backup which can be restored into
an alternative server
functions are tested at the normal
operating conditions, such as:
– Editing a method is audit trailed, and
creates new and old versions

©2016 Waters Corporation 64

 REPORTING Stage

Requirements Traceability Validation Summary Report

Matrix (RTM) (VSR)
Requirements are mapped from An outline of all testing
URS to CS to Test Scripts completed, including
The RTM document provides the – any deviations and discrepancies
level of detail necessary to encountered during the execution
understand: of the test plan as described in the
Validation Plan.
– How the system is configured
– A description of any outstanding
to meet requirements.
technical issues.
– Where test results are located for
each requirement. A description of essential
– The potential impact when activities needed to maintain the
considering a change to the system in compliance
system. A recommendation if the system
is fit for intended use.

©2016 Waters Corporation 65

 Managing Minor Change

Before implementing the After implementing the change:

change: Have the vendor repeat the SQT
Raise a formal change request for software on at least one client
Review the vendor Release Notes and one LAC/E32
to confirm the impact of the Record the new system
change is minimal component versions
Ensure the change request is Update the system
approved documentation (CS)
Close out the change request

©2016 Waters Corporation 66

 Managing Major Change

Before implementing the After implementing the change:

change: Have the vendor repeat the SQT
Raise a formal change request for software on all clients and
Assess the impact of the change LAC/E32
Update the Risk Assessment based Record the new system
on the change component versions
Create a roll back plan (in case Execute the testing against the
the change causes new problems) Test Plan
Create a Test Plan, based on the Update the system
updated Risk Assessment documentation (URS, CS, RTM…)
– What existing tests will be repeated Update the system SOPs
(regression testing) Review the testing and write a
– What new tests are needed (test Validation Report
scripts to be written and approved)
Close out the change request
Ensure the change request is
approved
©2016 Waters Corporation 67
 Waters Solution to meeting Today’s
Qualification Requirements

Empower SystemsQT (Qualification Tool)

Built into Empower (validated as part of Empower)
A complete solution for instruments controlled by Empower CDS
Secure and Auditable Qualification Data
– 21 CFR Part 11 Compliant Ready Qualification Data
– All of your data is maintained on your CDS
– On-Line Qualification Documentation for Easy Inspection
– Audit trails and method change control part of the data system
– No need for external spreadsheets or third party software
– Easy tracking and trending of qualification results
– Secure data environment
– On-line review and approval available

©2016 Waters Corporation 68

 More Advantages of using
Empower SystemsQT

Accurate Qualification Testing and Analysis

– Less opportunity for human error
– Measures peak areas, peak heights and retention times
accurately and consistently
– Custom field calculations and regression analysis
– Testing consistent from system to system
– Reduces time that system is off-line by about half
– Multiple systems can be qualified at once
– Qualifies software and systems in their analytical
configuration
– Qualifies using same peak processing and quantitation
algorithms as during use on CDS system of record
– Demonstrates system level fitness for chromatographic use
©2016 Waters Corporation 69
 Other Ways Waters can assist…

©2016 Waters Corporation

…Questions? 70
 Questions/Discussion

http://www.waters.com/waters/home.htm

©2016 Waters Corporation 71