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Controlled transitions (approvals, closures, effectiveness verification) require an electronic signature. When you sign, Invariant captures:
  • Signer identity and a re-verification of your credential at the point of signing
  • Timestamp and the meaning of the signature
  • The exact content/version being signed (the signature is bound to a content digest)
  • A linked, hash-chained audit entry
Signature records are append-only. See 21 CFR Part 11 / Annex 11.