nach der Bestellung gedruckt Neuware - Printed after ordering - 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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Bibliographic Details

Title: Validating Corporate Computer Systems : Good IT Practice for Pharmaceutical Manufacturers
Publisher: CRC Press
Publication Date: 2000
Language: English
ISBN 10: 1574911171
ISBN 13: 9781574911176
Binding: Buch
Condition: Neu
Dimensions: 260 millimeters width by 183 millimeters height by 34 millimeters depth
Weight: 1210 grams

About this title

Synopsis

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.

About the Author

Guy Wingate

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