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21 CFR Part 11 Compliance


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21 CFR Part 11 Compliance

For FDA-regulated manufacturers FDA 21 CFR Part 11 Compliance is a familiar and critical requirement. The regulation defines the criteria governing the use of electronic records and digital signatures to store, track and transfer records pertaining to the manufacture of their products. For manufacturers looking to use software to digitalize quality and operations processes, it’s critical that the software systems being used meet these requirements. Join us for this on-demand webinar to learn:

  • What FDA 21 CFR Part 11 Compliance Regulation is and Why it Matters
  • Why 90% of Quality Leaders Say Compliance is their Biggest Challenge
  • The 5 Key Elements of FDA 21 CFR Part 11 Regulation Compliance
  • How to Ensure Consistent Compliance and also Increase Operational Efficiencies