21 CFR Part 11

Understanding FDA’s Part 11 regulation:

In today’s world, much of our data is maintained in electronic format.  This means that we must protect and ensure the integrity and security of our electronic data, if we expect it to be reliable, reproducible and accurate.  In 1997, the FDA issued its regulation on Electronic Records and Electronic Signatures (21 CFR 11) which defines FDA’s criteria for considering electronic records and electronic signatures to be:

  • trustworthy
  • reliable
  • equivalent to paper records and handwritten signatures executed on paper

 The FDA has since issued several guidance documents (see Resources and Tools) to assist researchers in complying with this regulation, which remains in effect today.

FDA-regulated research must comply with FDA’s regulation on Electronic Records and Electronic Signatures, known as “Part 11” (21 CFR 11). 

When does Part 11 apply?

It applies to records:

  • in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements (predicate rules) set by the agency (FDA)
  • required to be maintained under predicate rules:
    • maintained in electronic format in place of paper
    • maintained in electronic format in addition to paper format and that are relied on to perform regulated activities
  • submitted to FDA in electronic format under predicate rules (even if such records are not specified in agency regulations)

What are Predicate Rules?

Any FDA regulation that requires certain records to be maintained or submitted to the agency

For example:

GxP is a general term to refer to FDA’s regulations governing:

  • Good Clinical Practice (GCP)
  • Good Manufacturing Practice (GMP)
  • Good Laboratory Practice (GLP)

The GxP regulations are the Predicate Rules that describe FDA’s requirements for the conduct of research performed under these regulations.  If the Predicate Rules require certain records to be maintained or submitted to the agency, and these records are in electronic format, then 21 CFR 11 applies. 

For example:

FDA’s regulation 21 CFR 50.27: Documentation of Informed Consent, is a Predicate Rule, which states the following:

“… informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy shall be given to the person signing the form…”

If a researcher conducting an FDA-regulated study wants to document a subject’s informed consent by obtaining an electronic signature and date from a subject or subject’s legally authorized representative, then the electronic system used to capture the electronic signature and date must meet the requirements of 21 CFR 11.