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Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

Stephen Robert Goldman

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Product Details
Author:
Stephen Robert Goldman
Publisher:
1st Book Library
Publication Date:
May 16, 2003
Number of pages:
472 pages
Binding:
Paperback or Softback
ISBN-10:
1410737446
ISBN-13:
9781410737441

Overview

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


  • | Author: Stephen Robert Goldman
  • | Publisher: 1st Book Library
  • | Publication Date: May 16, 2003
  • | Number of Pages: 472 pages
  • | Binding: Paperback or Softback
  • | ISBN-10: 1410737446
  • | ISBN-13: 9781410737441

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