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21 CFR Part 11 - Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry (Paperback) Loot Price: R1,922
Discovery Miles 19 220
Repayment Terms: R180 pm x 12*
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21 CFR Part 11 - Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry (Paperback):...

21 CFR Part 11 - Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry (Paperback)

Orlando Lopez

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Loot Price R1,922 Discovery Miles 19 220 | Repayment Terms: R180 pm x 12*

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Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.

General

Imprint: Crc Press
Country of origin: United Kingdom
Release date: September 2019
First published: 2004
Authors: Orlando Lopez
Dimensions: 254 x 178mm (L x W)
Format: Paperback
Pages: 243
ISBN-13: 978-0-367-39459-2
Categories: Books > Science & Mathematics > Biology, life sciences > General
Books > Medicine > General issues > Medical equipment & techniques > Medical laboratory testing & techniques
Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
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LSN: 0-367-39459-6
Barcode: 9780367394592

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