21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry - Softcover

López, Orlando

 
9780367394592: 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Softcover
ISBN 10: 0367394596 ISBN 13: 9780367394592
Publisher: CRC Press, 2019

Synopsis

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.

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About the Author

López, Orlando

"About this title" may belong to another edition of this title.

Publisher
CRC Press
Publication date
2019
Language
English
ISBN 10 
0367394596
ISBN 13 
9780367394592
Binding
Paperback
Edition number
1
Number of pages
260

Other Popular Editions of the Same Title

9780849322433: 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Featured Edition

ISBN 10:  084932243X ISBN 13:  9780849322433
Publisher: CRC Press, 2004
Hardcover