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Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry|Stephen Robert Goldman

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

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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

This item is Non-Returnable

Details

  • ISBN-13: 9781410737441
  • ISBN-10: 1410737446
  • Publisher: 1st Book Library
  • Publish Date: May 2003
  • Dimensions: 11.04 x 8.22 x 0.97 inches
  • Shipping Weight: 2.35 pounds
  • Page Count: 472

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