Validating Corporate Computer Systems : Good IT Practice for Pharmaceutical Manufacturers
Book Details
Format
Hardback or Cased Book
ISBN-10
1574911171
ISBN-13
9781574911176
Publisher
Taylor & Francis Inc
Imprint
CRC Press Inc
Country of Manufacture
US
Country of Publication
GB
Publication Date
May 31st, 2000
Print length
544 Pages
Weight
1,293 grams
Product Classification:
Medical laboratory testing & techniquesBiology, life sciencesPharmaceutical technology
Ksh 36,000.00
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One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems.
Written by experts, this book provides authoritative information and practical advice on validating corporate computer systems. It covers good IT practice and validation principles and presents case studies on EDMSs, EAM systems, LIMSs, and MRP II systems. Topics include the increasing role of IT systems within the modern pharmaceutical manufacturing plant and the move toward paperless manufacturing, how to develop an information strategy, the importance of demonstrating regulatory compliance, how to maintain validated systems, conduct supplier audits for software packages, hardware manufacturers, and software integrators, the practical implications of 21 CFR 11, and more.
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