Computer system validation

 Why Computer Validation ?
 List of Guidance Documents.
 General Principles of Software Validation.
 OTS Software Use in Medical Devices.
 Electronic Records, Electronic Signatures ( 21 CFR Part 11 )
 Guidance Document for Computerized System used in Clinical Trials.
 Validation of Electronic Spreadsheet.
 Introduction to Validation Master Plan.
 Definition of ERP System
 Possible Questions
 References
www.PharmInfopedia.com

Data and Information Management Systems
Problem Solving Applications
Communication Aids ( e- MAIL, DIMS )
Laboratory Automation ( LIMS, HPLC, DISSOLUTION,
MICROBALANCES )
Process Control
Computerised System used for Clinical Trials and Manufacturing of
Medical Devices

April 1999 Computerized Systems Used in
Clinical Trials
September 1999 Off-The-Shelf Software Use in
Medical Devices
August 2001 Electronic Records; Electronic
Signatures – Validation
January 2002 General Principles of Software
Validation
August 2003 Electronic Records; Electronic
Signatures - Scope and
Application
21 CFR Part 11 Electronic Records; Electronic
Signatures
21 CFR Part 820 Quality System Regulation

Software used as a component, part, or accessory of a
medical device
Software that is itself a medical device
Software used in the production of a device
Software used in implementation of the device
manufacturer's quality system
January 11, 2002,
CDRH, CBER www.PharmInfopedia.com

Least Burdernsome and Specific Approach
SOFTWARE
VALIDATION
Validation during each activity of
life cycle model
21 CFR Part 820
OTS Software Validation
(device manufacturer
responsible)
Simulated Use Environment and
User Site Testing
Overall design validation for the system
Validation Coverage / Extent of Validation
Validation Documentation
Self-Validation not followed
Validation Master Plan
Premarket Submission to :
ODE
CDRH
CBER
Postchange Software Validation
Documentation Updation

Quality Planning
System Requirements Definition
Detailed Software Requirements Specification
Software Design Specification
Construction or Coding
Testing
Installation
Operation and Support
Maintenance
Retirement

Guidance for premarket submission to FDA
3 Level of Concerns
Documentation ( Basic and Special)
Corneal Topographer (Minor Level of Concern Device)
Implantable Medical Device Programmers (Major Level of Concern
Device)
September 9, 1999www.PharmInfopedia.com

21
C
F
R
P
A
R
T
11
 Was issued in March 1997
 Records in electronic form that are created,
modified, maintained, archived, retrieved, or transmitted
 Submission to FDA and also to comply with Predicate Rules
(The Act ,The PHS Act)
 Three major concerns demanded the revision of 21 CFR Part 11
1. unnecessarily restrict the use of electronic technology
2. significantly increase the costs of compliance
3. discourage innovation and technological advances
 Revised and issued in August 2003

WHAT DOES PART 11 REQUIRE

Records maintained in electronic format in place of paper format
(PredicateRules and FDA)
No predicate rule requirement but it is in electronic format --- No CFR Part 11
Records maintained in electronic format in addition to paper format
(Predicate Rules and FDA)
Records maintained in electronic format
(Predicate Rules, but not required by FDA)
Electronic Record used for generating submission if not required by Predicate
Rules is not a part of CFR Part 11 and vice versa
Electronic signatures that are intended to be the equivalent of handwritten
signatures, initials, and other general signings (Predicate Rules)

Validation
Audit Trail
Legacy Systems
Copies of Records
Record Retention

System Requirements Specifications
Documentation of Validation Activity
Dynamic Testing
Static Verification Techniques
Extent of Validation
Independence of Review
Revalidation

Documentation of user requirements/intended
use
Computer system implements needs correctly
Documentation of Validation Activity
Validation Plan
Validation Procedure
Validation Report

Key testing consideration
Testing Condition
Normal
Stress
Actual Performance Testing
Simulation Test
User-Site Test
Software testing
Structural Testing (White Box Testing)
Functional Testing (Black Box Testing)
Program Build Testing

Static analyses
Technical reviews
Extent of Validation
Risk with the system
System’s Complexity

Third Party
Person of the Organisation
Revalidation
As per requirement of user
By system upgradation
During routine servicing and maintenance
Network like internet

IS IT NECESSARY TO VALIDATE COMPUTERIZED
SYSTEMS USED IN CLINICAL TRIALS
April 1999 USFDA

 Automating analytical data calculations from various laboratory
analyses
 Tracking and summarizing product complaints
 Gathering and summarizing clinical trial data collection and
analyses
 Validation of Electronic Spreadsheet is necessary in order to
evaluate key drivers : Authenticity, Data and System Integrity, and
Confidentiality
 Should comply with Predicate Regulations
21 CFR Part 11

ELECTRONIC
SPREADSHEET
YEAR OF DEBUT LAUNCHER
VisiCalc 1978 Harvad Business School
Lotus 1-2-3 1983 IBM
Excel 1984 Microsoft Corporation

Preparation of test cases/test procedures for each functional
element defined. Test case must challenge the operation and
performance of the system especially for its most critical
parameters
Execution of the test cases and the results must be recorded
Evaluate whether software has been validated for its intended
use
Documented evidence of all testing procedures, test input data,
and test results must be retained

"HOW MUCH VALIDATION IS ENOUGH ?"
"WHICH SYSTEMS DO WE HAVE TO VALIDATE ?“
“HOW TO COORDINATE THE VALIDATION EFFORTS ?”
“HOW TO MAKE VALIDATION EFFORT WITHIN THE
BUDGET ?”

 Integrates planning, manufacturing, distribution, shipping, and
accounting into a single system
 Designed to serve the needs of each different department within the
enterprise
 Creates supply chain management
 An ERP implementation can cost millions of dollars to create, and may
take several years to complete
 Implement ERP in a more incremental fashion
 Tremendous advantages:
1. Share information
2. Workflow becomes more automated
3. It can speed up the manufacturing process by automating
processes and workflow
4. It also reduces the need to carry large inventories.www.PharmInfopedia.com

 According to your view point, Why it is necessary to validate
“Computer” ? [ 2 marks ]
 State the general principles of Software Validation. [ 5 marks ]
 What is OTS Software ? How the level of concern affect the
documentation of OTS software validation ? [ 2 marks ]
 State the key principles of validating Electronic Records and Electronic
Signatures. [ 5 marks ]
 How will you validate the Electronic Spreadsheet ? [ 2 marks ]

General Principles of Software Validation; Final Guidance for Industry and
FDA Staff, January 11, 2002.
(http://www.fda.gov/cdrh/comp/guidance/938.html)
Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf
Software Use in Medical Devices, September 9, 1999.
(http://www.fda.gov/cdrh/ode/guidance/585.html)
Guidance for IndustryPart 11, Electronic Records; Electronic Signatures –
Scope and Application, August 2003.
(http://www.fda.gov/cder/guidance/5667fnl.htm)
Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures
Validation, August 2001.
(http://www.fda.gov/ohrms/dockets/98fr/001538gd.pdf)
Guidance for Industry, Computerized Systems used in Clinical Trials, April
1999.
(http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm)www.PharmInfopedia.com

US Food and Drug Administration, Center for Devices and Radiological
Health, Code of Federal Regulations, Title 21, Part 11, Volume 1, Electronic
Records and Electronic Signatures, Revised as of April 1, 2005
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?
CFRPart=11&showFR=1)
Computer Validation Guide, Final Draft, Version 2, December 2002.
(http://apic.cefic.org/pub/compvalfinaldraftDecember2002.pdf)
Technical Considerations for the Validation of Electronic Spreadsheets or
Complying with 21 CFR Part 11 by Taun T. Phan, Pharmaceutical Technology,
January 2003.
(www.pharmtech.com)
Computer Validation Master Planning “Validation Strategies” by Michael
Schousboe, Pharmaceutical Technology, November 1, 2005.
(www.pharmtech.com)
Computers in Pharmaceutical Technology, Encyclopedia of Pharmaceutical
Technology, Volume 3.

Computer system validation

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