Cover image for Validating pharmaceutical systems : good computer practice in life science manufacturing
Title:
Validating pharmaceutical systems : good computer practice in life science manufacturing
Author:
Andrews, John.
ISBN:
9780203500439

9781135487942

9781135487980
Physical Description:
1 online resource (xix, 549 pages)
Contents:
chapter 1 Considerations for Computerized System -- chapter 2 An Inspector's Viewpoint -- chapter 3 State-of-the-Art Risk Assessment and -- 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 -- chapter 8 Good Documentation in Practice -- chapter 9 Good Testing Practice: Part 1 -- chapter 10 Enterprise Resource Planning Systems -- chapter 11 Calibration in Practice -- chapter 12 Validating Legacy Systems -- chapter 13 Technology Transfer Keys -- chapter 14 Qualifying SCADA Systems in Practice -- chapter 15 The Application of GAMP 4 Guidelines to -- chapter 16 The Validation of a LIMS System�A Case -- chapter 17 Compliance and Validation in Central and -- chapter 18 Distribution Management Validation in -- chapter 19 Good Testing Practice: Part 2 -- chapter 20 Practical Applications of GAMP Version 4.
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E-Book 540260-1001 RS122.2 .V35 2005
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