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28 reviews(Ebook) Validating Pharmaceutical Systems Good Computer Practice in Life Science Manufacturing 1st Edition by John Andrews - Ebook PDF Instant Download/Delivery: 9780203500439 ,B00SC8L32Q
Full download (Ebook) Validating Pharmaceutical Systems Good Computer Practice in Life Science Manufacturing 1st Edition after payment
Product details:
ISBN 10: B00SC8L32Q
ISBN 13: 9780203500439
Author: John Andrews
(Ebook) Validating Pharmaceutical Systems Good Computer Practice in Life Science Manufacturing 1st Edition Table of contents:
Chapter 1 Considerations for Computerized System Validation in the 21st Centu ry Life Sciences Sector
Chapter 2 An Inspector’s Viewpoint
Chapter 3 State-of-the-Art Risk Assessment and Management
Chapter 4 Validation Planning and Reporting
Chapter 5 Supplier Audits: Questions and Answers
Chapter 6 Developing Good Specifications
Chapter 7 Traceability of Requirements Throughout the Life Cycle
Chapter 8 Good Documentation in Practice
Chapter 9 Good Testing Practice: Part 1
Chapter 10 Enterprise Resource Planning Systems — Aligning Business andVali dation Requirements
Chapter 11 Calibration in Practice
Chapter 12 Validating Legacy Systems
Chapter 13 Technology Transfer Keys
Chapter 14 Qualifying SCADA Systems in Practice Acquisition*
Chapter 15 The Application of GAMP 4 Guidelines to Computer Systems Found inGL P-Regulated Areas
Chapter 16 The Validation of a LIMS System
Chapter 17 Compliance and Validation in Central and Eastern Europe(CEE)
Chapter 18 Distribution Management Validation in Practice
Chapter 19 Good Testing Practice: Part 2
Chapter 20 Practical Applications of GAMP Version 4
Chapter 21 Glossary and Abbreviations
Index
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Tags: John Andrews, Validating Pharmaceutical Systems, Computer Practice, Life Science Manufacturing