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Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers - Softcover

 
9780367398569: Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers
Softcover
ISBN 10: 0367398567 ISBN 13: 9780367398569
Verlag: CRC Press, 2019

Inhaltsangabe

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.

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Über die Autorin bzw. den Autor

Guy Wingate

Von der hinteren Coverseite

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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Verlag
CRC Press
Erscheinungsdatum
2019
Sprache
Englisch
ISBN 10 
0367398567
ISBN 13 
9780367398569
Einband
Taschenbuch
Anzahl der Seiten
526
Herausgeber
Wingate Guy
Kontakt zum Hersteller
preigu GmbH & Co. KG
mail@preigu.de

Lengericher Landstr. 19
Osnabrück
Niedersachsen
49078
Deutschland