21 CFR Part 11

21 CFR Part 11
Author :
Publisher : CRC Press
Total Pages : 287
Release :
ISBN-10 : 9781135488758
ISBN-13 : 1135488754
Rating : 4/5 (58 Downloads)

Book Synopsis 21 CFR Part 11 by : Orlando López

Download or read book 21 CFR Part 11 written by Orlando López and published by CRC Press. This book was released on 2004-01-15 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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


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Have new functions been added that could impact the integrity and accuracy of electronic records? What is the duration of use and how does it relate to the expi