Validation of Equipment and Computer

Systems in Laboratories
February 2004

Ludwig Huber
Compliance Fellow for
Life Sciences and Chemical Analysis

Chairperson: Ingrid Ginnutt

Content
• Validation planning
• Qualification during installation and use
• Change control
• Legacy systems
• Macros and spreadsheets
• Network qualification
• Vendor contributions

Reference material:
www.labcompliance.com/agilent/computervalidation

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 Validation in the Analytical Laboratory

Prove suitability for

intended use

Equipment
qualification
(components Analysis
hardware and systems) method
IQ/OQ
software analysis report

System
suitability
testing and routine
PQ quality control (QC)

Reviews
• Primary
• Secondary
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Qualification/Validation Phases
4Q Model
O User requirement specifications
Design Qualification O Functional specifications
O Operational specifications
O Vendor qualification

Installation Qualification O Check arrival as purchased

O Check proper installation of
hardware and software

Operational Qualification O Test of operational functions

O Performance testing
O Test of security functions

O Test for specified application

Performance Qualification O Preventive maintenance
O On-going performance tests

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Validation Master Plan - Purpose

• Increases significantly efficiency and

consistency of individual validation projects For:
• corporate
• Answers the inspector’s question:
• site
“What is your company’s approach
• department
towards validation?”
• specific systems
• Required EU GMP (Annex 15)
“Validation and Qualification”

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Validation Master Plan - Contents

O Scope, e.g., for all regulated an ISO7025 environments

O Glossary, e.g., validation, qualification
O Responsibilities, e.g., QA
O Steps/approaches for validation and testing, e.g., DQ,
IQ, OQ, PQ
O Criteria and examples for risk assessment
O Release procedure, e.g., who has to approve
O Discontinuance
O Content of validation report
O Documentation and archiving

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Design Qualification -
Purpose

• Helps in all later phases, e.g., OQ and PQ testing

• Answers the inspector’s questions:
“What is the system doing and what are the system
requirements and specifications?”
• Required by EU GMP (Annex 15)
“Qualification and Validation”

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 Design Qualification -
Contents

• Description of the application and intended use of

the equipment
• Description of the intended environment
• User requirement specifications
• Functional and performance specifications
• Qualification of the vendor

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Steps for Vendor Assessment
• Evaluation through references
• Evaluation through own experiences
(in general, product specific)
• Mail audit
(response to checklists)

• 3rd party audit

• Audit through user’s firm
(general, project specific)

FDA Validation Guidance: The evaluation (of a supplier’ SW

development activities) should preferably be derived from a
reliable audit of the software developer, performed by the end
user's organization or a trusted and competent third party.

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Example - Agilent Validation CD

• Available to customers under confidentiality agreement

• Can minimize the need for on-site audits

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Question and Answer Session

No. 1

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Installation Qualification -
Purpose

• Make sure everything is there as purchased

• Make sure software is ‘properly’ installed and
systems are properly configured
• Required by regulations and standards

Have all information available for troubleshooting

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Installation Qualification -
Steps
• Compare equipment, as received,
with purchase order
• Check documentation for completeness
• Install hardware (computer, printers, network cables)
• Install software and check correct installation
• Reboot and ensure that all modules power up and perform
an electronic self-test
• Document all components with asset and serial numbers

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Example: Check Proper SW Software
File name File Description
Missing files
1\instrmnt.ini Initialization
repstyle\library.mac Macro
1\verify\default.val\integ.reg Register
helpenu\hpsc6a00.hlp Help
Changed files
core\800\eevempt.ini Initialization
core\800\eevtool.ini Initialization
Identical files
apg_top.exe HP APG DataComn
apgdde.dll HELP

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Example: IQ Documentation

• Documentation of all hardware and system software

• Performed by vendor or customer with training and certification

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Operational Qualification -
Purpose

• Check suitability of equipment hardware/software in the

user’s environment

• Required by regulations and standards

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Operational Qualification -
Steps
• Define critical functions for the computer system
as defined in DQ
• Develop test cases for the functions and
define acceptance criteria
• Perform the tests
• Evaluate results and compare with acceptance
criteria
• Document results

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Key Points for OQ Tests

• Tests should be linked to user requirement

and functional specifications (test
traceability matrix) URS
• Test cases should include normal and
stress conditions FS
• Tests should be quantifiable
Test
• Test cases should be designed for reuse

FDA Validation Guidance: Test conditions: test conditions should

include not only "normal" or "expected" values, but also stress
conditions (such as a high number of users accessing a network at the
same time).

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Example: OQ Documentation

• Protocol review and approval by customer and Agilent

• System Challenges and documentation of results
• Final Sign off with deviations and necessary supporting documents

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OQ - Computerized Systems

• Install all hardware and software

• Verify complete software installation
• Qualify equipment hardware and complete system
• Make additional tests for the software part, e.g., limited
access and electronic audit trail

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Performance Qualification -
Purpose

• Ensures that the system and application work as

intended day in day out

• Answers the inspector’s question:

“How are are you sure that the application works
as intended day-by-day?”

• Helps to prevent errors

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Performance Qualification -
Steps
Develop and implement procedures for:

• Preventive maintenance of hardware

• Recalibration of equipment
• Back-up and disc maintenance, removal of temp
files and virus checks

• Regular system performance tests, for example

system suitability testing

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 Ongoing Performance Qualification

• Early maintenance feedback to prevent errors

• Preventive maintenance for hardware to ensure on-
going function and performance
• Re-qualification for hardware after updates and repair
• Software for automated system suitability testing and
analysis of quality control samples (chemical
performance tests)
• On-line monitoring tools of network performance and
connectivity

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System Suitability Testing
Why ?
• Makes sure that systems and applications work
on day-by-day basis

When
• Before, during and maybe after routine
sample analysis
• Daily
What ?
• Any critical parameter which may be for HPLC
• Precision of retention times, peak areas
• Resolution between two peaks
• Tailing factor (in chromatography)
• Other parameters optional

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Question and Answer Session

No. 2

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Lifecycle Model for Spreadsheets&Macros
Change control

User requirement/ Installation and

Functional Specific. test in user environ.

Design Installation+Test
Specifications in test environment

Code development
Code review
Can be
combined for
single users
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Change Control

• Main reasons for changes: hardware maintenance and

repair and software upgrades

• Changes must follow a documented change procedure

• Procedure should require risk analysis and evaluation if the

change may affect the computerized system's validation
status

• Document changes; what, why, who, how tested?

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Legacy/ Existing Systems

• Follow computer validation/qualification practices

• Follow lifecycle approach (4Q model)
DQ
• May not have info from vendor, but lot’s of
experience IQ
• Describe what the system is doing, how it is being
used, and what functions it has OQ
• Document installation
• Document past tests or develop new ones PQ
• Declare the system as validated

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Networks - Know Everything at Any Time

CS01 CS02

CORE
SD FIBER

N03 N05 N04 N02 N01

ACCESS Network `GB-Ethernet

WAN
05

SV04

Security
DH08
DH09 SV03
DH01 DH07
DH04

DH02
DH03 DH08
DH06
DH05

SV01
SV02
Data integrity
DISTRIBUTION 100BaseT Uptime
`

Review
Clients

Bench 1 Bench 2 Bench 3

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The Approach for Networks

• Qualify Network Infrastructure

- document baseline
- check connectivity and bandwidth

• Validate Networked Systems/Applications

• Develop and implement rigorous configuration management

and change control procedures

• Monitor network connections and traffic using a network

health monitoring software for this.

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Example:
Agilent Networked Data Systems
Agilent Technologies Provides for
Networked Systems
• IQ/OQ of networked system
(C/S Chromatographic data system)
• Guidance & Documentation to support
retrospective DQ and IQ
• Mapping network topology
• Determination of network bandwidth &
utilization
• Continuous Monitoring of network health
Scaleable LAN based Client/Server Chromatographic Data System
To find out more about Agilent’s compliance program please visit the
website www.agilent.com/chem/compliance.

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Agilent Advisor - Monitoring Tool

Monitoring
Mapping
Warnings
Topology
Monitoring
Bandwidth
Is the HPLC
still connected
to the LAN?

http://onenetworks.com
LAN Analyzer
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Qualification/Validation Report
• Response to validation plan
• Qualification/validation approach
• Describes application, use
and environment of system

• Summarizes test plan/acceptance criteria/results

• Authorizes use of system

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 Final

Question and Answer Session

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 Agilent Technologies Offerings for
Validation of Software and Computer
Systems

• Help with design qualification, e.g., provide specifications

• Provide CD with development validation documents
• Offer and assist users during vendor audits
• Provide services for installation qualification and operational
qualification of equipment hardware and computer systems
• Automated OQ testing reduces system downtime
• Provide tools and services for network infrastructure qualification
• Services offered worldwide and for for instruments from multiple
vendors

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Further Information

To attend the Agilent e-seminar series, please visit

our WEBSITE:

http://www.agilent.com/chem/eseminars-compliance

For further information on our products and services

please contact your local Agilent Office.

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