Food and Drug Administration Code of Federal Regulations, Title 21, Part 11 (FDA 21 CFR Part 11)

The regulations in FDA 21 CFR Part 11 set necessary criteria for electronic records and signatures to be considered reliable, trustworthy, and equivalent to paper versions. These regulations apply to:

  • Electronic records
  • Electronic signatures
  • Handwritten signatures executed on electronic records

Where does CFR Part 11 apply?

Any departments taking part in drug trials should comply with CFR Part 11.

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