21 CFR Part 11
Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
1st Edition
Published on 15. January 2004
243 pages
978-1-135-48875-8 (ISBN)
Description
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
More details
Edition
1. Auflage
Language
English
Place of publication
London
United Kingdom
Publishing group
Taylor & Francis Ltd
Target group
Professional and scholarly
Product notice
Reflowable
Illustrations
23 schwarz-weiße Abbildungen
ISBN-13
978-1-135-48875-8 (9781135488758)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Orlando Lopez
21 CFR Part 11
Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Book
09/2019
1st Edition
CRC Press
€93.90
Shipment within 15-20 days
Orlando Lopez
21 CFR Part 11
Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Book
01/2004
1st Edition
CRC Press
€272.60
Shipment within 15-20 days
Content
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance. The author introduces appropriate 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. The material is presented through practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.
