21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry, 1st Edition (e-Book) book cover

21 CFR Part 11

Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry, 1st Edition

By Orlando López

CRC Press

243 pages

Purchasing Options:$ = USD
Hardback: 9780849322433
pub: 2004-01-15
$210.00
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eBook (VitalSource) : 9780429216381
pub: 2004-01-15
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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

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology