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.

• Format: Paperback
• Language: English
• ISBN: 0367394596
• ISBN13: 9780367394592
• Release Date: September 2019
• Publisher: CRC Press
• Length: 260 Pages
• Weight: 0.95 lbs.
• Dimensions: 0.6" x 6.9" x 9.9"