An Easy to Understand Guide to 21 CFR Part 11

Author: Orlando Lopez, Graham O'Keeffe
Edition: 2010
File Size: 24.9 MB
Format: PDF
Language: English
Provider: AskaboutValidation

Price: $19.99
Product Details

If you've decided to invest some time in reading this book, I am making the assumption that you are pretty tired of wading through the regulations developed by the FDA that were designed to confuse the hell out of everyone! Our easy to understand guide is the ultimate solution to guide you through all of these regulations in a clear and concise manner.

The training includes:

  • What is 21 CFR Part 11;
  • E-Records;
  • E-Records Not Impacted by Part 11;
  • Electronic Signatures;
  • Automatic log out;
  • Validating Operational Checks;
  • Authority Checks;
  • Device Checks;
  • Methods of Authentication;
  • Open Vs Closed Systems;
  • and much much more..

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