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

Brossura

ISBN 10: 0367398567 ISBN 13: 9780367398569

Casa editrice: CRC Press, 2019

Riassunto

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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Informazioni sull'autore

Guy Wingate

Dalla quarta di copertina

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.

Dettagli dell'edizione

• Editore: CRC Press
• Data di pubblicazione: 2019
• Lingua: Inglese
• ISBN 10: 0367398567
• ISBN 13: 9780367398569
• Rilegatura: Copertina flessibile
• Numero edizione: 1
• Numero di pagine: 544
• Redattore: Wingate Guy
• Contatto del produttore: Taylor and Francis, GPSR Taylor and Francis; gpsr@taylorandfrancis.com; ; Taylor & Francis Verlag GmbH, Kaufingerstraße 24; München; 80331; Germania