Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

by Stephen Robert Goldman

Overview

This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsib

Product Details

ISBN-13:	9781410737441
Publisher:	AuthorHouse
Publication date:	05/16/2003
Series:	1st Books Library
Pages:	472
Product dimensions:	8.22(w) x 11.04(h) x 0.97(d)

Table of Contents

	Preface	iii
	Introduction	vii
Part 1	Overview	1
Chapter 1	A Brief History	3
	Origins of the Modern FDA in Brief	3
	The Increasing Role of Computers	5
	Advent of 21 CFR Part 11	6
	Current Practice and Regulation	6
Chapter 2	Planning, Assessment, Implementation and Remediation	9
	Roles and Responsibilities	9
	Jargon	10
	System Development Life Cycle (SDLC) Stages	12
	How To Set Up Planning	12
	How To Prepare For Basic Computer Validation	13
	Identifying Procedural Controls	13
	Identifying System Controls	14
	Implementing Measures	14
	Preparing Reports	14
	Effective Closure	15
	What's Next	15
Chapter 3	Overview of Computer and Computerized System Validation	17
	IT/IS Infrastructure	17
	Validation	20
Chapter 4	Roles and Responsibilities in Computer and Computerized System Validation	39
	Roles and Responsibilities	39
	Procedure	48
Part 2	Standard Operating Procedures for Validation	51
Chapter 5	Regulatory Requirements, Policies, Guidelines and Standard Operating Procedures	53
	FDA's Mission	53
	Regulations	53
	Policies	54
	Guidelines	55
	Standard Operating Procedures	55
Chapter 6	The SOP on SOPs	57
	Title Block	57
	Approval Section	58
	Table of Contents	58
	Purpose	58
	Scope	59
	Equipment/Materials/Tools	59
	Warnings/Notes/General Information/Safety	59
	Policies, Guidelines, References	59
	Assumptions/Exclusions/Limitations	60
	Glossary of Terms	60
	Roles and Responsibilities	60
	Procedure	60
	Figure 2 - Periodic Review Completed	72
	Document Management and Storage	74
	Revision History	74
	Attachments	74
Chapter 7	Project Plan	77
Chapter 8	Validation Plan	89
Chapter 9	Design Qualification	105
	Requirements and Specifications	106
	Traceability Matrix	106
	Vendor Qualification	106
	Manuals and SOPs	107
	Training	107
	Ongoing Operation Requirements	107
	Design Qualification Report	107
	21 CFR 820.30 Quality System Regulation: Design Controls	107
Chapter 10	User Requirements	111
Chapter 11	Functional Requirements	121
Chapter 12	Vendor Audit	133
Chapter 13	Software Design Specification	143
Chapter 14	Hardware Design Specification	157
Chapter 15	Testing	169
	Unit Testing	169
	Factory Acceptance Testing	169
	End-User Testing	169
	Qualification Tasks	170
	Analysis	170
	Construction	171
Chapter 16	Unit Testing	173
Chapter 17	Factory Acceptance Testing	187
Chapter 18	Hardware Installation Qualification	203
Chapter 19	Hardware Operational Qualification	217
Chapter 20	Software Installation Qualification	231
Chapter 21	Software Operational Qualification	245
Chapter 22	Performance Qualification	259
Chapter 23	Electronic Records; Electronic Signatures	273
Chapter 24	21 CFR Part 11 Assessment	287
Chapter 25	Summary Reports	297
Chapter 26	Traceability Matrix	303
Chapter 27	Change Control	311
Chapter 28	Document Management and Storage	319
Chapter 29	Configuration Management	335
Chapter 30	Periodic Review	345
Chapter 31	Manuals and SOPs	355
Chapter 32	Logs	363
Chapter 33	Training	371
Chapter 34	Project Validation Final Report	381
Chapter 35	Ongoing Operation	387
Chapter 36	Decommissioning and Retirement	397
Chapter 37	Validation Master Plan	407
Chapter 38	Gap Analysis and Retrospective Validation	419
	Further Reading	431
	Appendix	435
Appendix 1	21 CFR Part 11	437
Appendix 2	Good Laboratory Practices - Attachment A	443
Appendix 3	Roles and Responsibilities--Validation	446
	Index	449