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

by Orlando Lopez

Book Overview

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...

• Format: Hardcover
• Language: English
• ISBN: 084932243X
• ISBN13: 9780849322433
• Release Date: January 2004
• Publisher: CRC Press
• Length: 260 Pages
• Weight: 1.40 lbs.
• Dimensions: 0.8" x 7.2" x 10.3"