Computer system validation

www.PharmInfopedia.com

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

Referenceswww.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 andUser 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

CDRHCBER

Postchange Software ValidationDocumentation Updation


Quality Planning System Requirements Definition Detailed Software Requirements

Specification Software Design Specification Construction or Coding Testing Installation Operation and Support Maintenance Retirement www.PharmInfopedia.com

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)www.PharmInfopedia.com

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 www.PharmInfopedia.com

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 TestSoftware testing Structural Testing (White Box

Testing) Functional Testing (Black Box

Testing) Program Build Testingwww.PharmInfopedia.com

Static analyses Technical reviews

Extent of Validation

Risk with the systemSystem’s Complexity


Third PartyPerson 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 USFDAwww.PharmInfopedia.com

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


ELECTRONICSPREADSHEET

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)


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.



Education

Computer system validation