Every change to a controlled document flows through a Change Request and requires a verified, MFA-backed eSignature at merge. Hash-chained. Timestamped against a canonical clock. 21 CFR Part 11 §11.200(a) compliant.
TOTP authenticator code at merge time. The system blocks the merge until the right person enters the right code. No workarounds.
Signers confirm what they're approving — not just that they clicked a button. Per 21 CFR Part 11 §11.100, the signature is legally binding.
Each signature references the SHA-256 hash of the previous event. A single altered record breaks the chain. Your auditor can verify it themselves.