Validation Compliance Annual: 1995

Front Cover
CRC Press, Feb 17, 1995 - Science - 1200 pages
"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."

From inside the book

Contents

Preface
1
Government Regulation
23
FDA Regulations
31
EPA Regulations
204
European Union Regulations
237
Situational Review
304
Tools for Validation
346
304
408
Electronic Signatures
468
Field Findings
910
Sixteen Theses
962
Future Developments
969
Appendices
987
Index
1092
Copyright

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