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21 CFR Part 11

What Does it Mean?

21 CFR Part 11 refers to the automated collection, processing and analysis of research information which results in the creation of an electronic record. This regulation assures the US Food and Drug Administration that the electronic content is the same as what would be found in paper records. This also requires electronic medical record users to have controls in place such as audit trails and system validations to ensure that the record cannot be manipulated.

When Does it Apply?

Part 11 applies to electronic records that are created, modified, maintained, archived, retrieved, or transmitted to the FDA.

  • Electronic Signatures
  • Electronic Records

What Might You be Asked?

Study sponsors might ask you to document compliance with these regulations by signing a form or mailing a statement to the FDA certifying that some or all parts of the system are compliant.

How to answer when asked to certify compliance?

If requested to provide documentation of compliance on this topic, email the Research Help Desk for current University responses that are appropriate to your study, before signing anything.