21 CFR Part 11 Checklist

Does your organization need to comply with the United States Food and Drug Administration (FDA) Title 21 CFR Part 11?

Life sciences organizations such as pharmaceutical, biotechnology companies, medical device manufacturers, and food manufacturers must abide by stringent compliance requirements. US FDA Title 21 CFR Part 11 is an important regulation that all firms in these sectors need to consider.

Download this checklist for answers to common questions about 21 CFR Part 11, such as:

  • What is 21 CFR Part 11? What is an electronic signature? What is software validation?
  • What the 21 CFR Part 11 clauses mean with respect to training records
  • Best practices around 21 CFR Part 11 requirements for electronic signatures and auditing
  • What a successful company validation process for a Learning Management System (LMS) entails

Download the Report

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