The trigger

An assistant drafts Rev 4.0 of a finished-product specification. The generated document is well-formatted and passes document-control review. However, one testing limit has no source in method transfer or validation records.

What existing controls miss

Document control catches the wrong version. Change control catches the unapproved change. Neither catches a current, properly approved specification containing a limit that nothing supports.

FDA applied existing 21 CFR 211.22(c) in an April 2026 warning letter on AI-generated documentation. There is no new AI rule in that sentence: the Quality Unit must have adequate laboratory facilities and records to support approval.

Automation boundary

  • Do not automate: Drafting specs directly from unverified PDFs into approval without a sealed source pack.
  • Must stay human: Declaring the source set, accepting limit changes, and Quality Unit approval.
  • Process fix: Split review into form review vs traceability review.