Validation Compliance Annual: 1995

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CRC Press, 17. feb. 1995 - 1200 sider
"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."

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Innhold

Preface
1
Government Regulation
31
Situational Review
304
Tools for Validation
346
in System Validation
408
509
858
Field Findings
910
Sixteen Theses
962
Future Developments
969
Appendices
987
987
1059
Index
1092
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