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OverviewSince 1994, the German GMA-NAMUR, German APV, ISPE-Baseline, OECD, UK GAMP Forum, UK IQA-PQG, US DIA, ISPE, and PDA initiatives have supplemented the regulations governing the validation of automated systems with high-level guidelines. The result has been a broadly accepted industry framework for validating automation systems. It includes Good Automated Manufacturing Practice (GAMP), Good Automated Laboratory Practice (GALP), and Good Information Technology Practice (GITP). This book deals directly with project problems and their resolutions based upon the experience of established industry practitioners. The first part introduces the principles of good practice and why validation is needed, concluding with the Ten Commandments for Validating Automation. The second part presents a comprehensive selection of case studies (provided by industry experts). Full Product DetailsAuthor: Guy Wingate (GlaxoSmithKline)Publisher: Taylor & Francis Inc Imprint: CRC Press Inc Dimensions: Width: 17.80cm , Height: 4.10cm , Length: 25.40cm Weight: 1.370kg ISBN: 9781574910377ISBN 10: 157491037 Pages: 592 Publication Date: 30 June 1997 Audience: General/trade , College/higher education , Professional and scholarly , General , Undergraduate Format: Hardback Publisher's Status: Out of Stock Indefinitely Availability: Awaiting stock  Table of ContentsReviewsAuthor InformationTab Content 6Author Website:Countries AvailableAll regions |
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