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

 
9780367398569: Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

Sinopsis

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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Acerca del autor

Guy Wingate

De la contraportada

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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Otras ediciones populares con el mismo título

9781574911176: Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

Edición Destacada

ISBN 10:  1574911171 ISBN 13:  9781574911176
Editorial: CRC Press, 2000
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