Validation Compliance Annual: 1995

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International Validation Forum (International Validation Forum, Boothwyn, Pennsylvania, USA)

Validation Compliance Annual

1995

International Validation Forum (International Validation Forum, Boothwyn, Pennsylvania, USA)

$735

Hardback

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English

CRC Press Inc
17 February 1995

Analytical chemistry; Ethical & social aspects of computing; Legal aspects of computing

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.

By: International Validation Forum (International Validation Forum Boothwyn Pennsylvania USA)
Imprint: CRC Press Inc
Country of Publication: United States
Dimensions: Height: 254mm, Width: 178mm, Spine: 58mm
Weight: 2.131kg
ISBN: 9780824794590
ISBN 10: 0824794591
Pages: 1110
Publication Date: 17 February 1995
Audience: College/higher education , Professional and scholarly , Further / Higher Education , Undergraduate
Format: Hardback
Publisher's Status: Active

Overview - behind validation, the regulatory world; government regulation - FDA regulation, EPA regulations, European union regulations; situational review - situational review by industry, situational review in the USA, international situational review; tools for validation - validation checklist, the use of an SDLC in system validation, data integrity and security, documentation - the SOP, electronic signatures, drug inspections, biologics inspections, medical device inspections, hazard analysis; field findings - FDA adverse findings, case study experience - sixteen theses; future developments - future developments. Appendices: glossary; validation bibliography.

International Validation Forum