Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
Author | : Stephen Robert Goldman |
Publisher | : 1st Book Library |
Total Pages | : 480 |
Release | : 2003 |
ISBN-10 | : UOM:39015058098412 |
ISBN-13 | : |
Rating | : 4/5 (12 Downloads) |
Download or read book Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry written by Stephen Robert Goldman and published by 1st Book Library. This book was released on 2003 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsib