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Nothing merges without your signature.

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.

app.lightworks.md/qms/cr/CR-218
eSign & Approve
CHANGE REQUEST
CR-218
Update SOP-014
Model Retraining
STATUS
In Review
AUDITOR
Harmony Cobel
Mr. Milchick
Mark S.
SOP-014
Retraining cadence: every 180 days
+Every 90 days, drift ≥ 0.04 KS triggers ad-hoc retrain
BLOCKINGQM eSignature required · 21 CFR Part 11 §11.200(a)
eSign to Merge
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I agree this signature is legally binding per 21 CFR Part 11.
Harmony Cobel
01

MFA assertion on every merge

TOTP authenticator code at merge time. The system blocks the merge until the right person enters the right code. No workarounds.

02

Stated intent, not just a click

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.

03

Tamper-evident hash chain

Each signature references the SHA-256 hash of the previous event. A single altered record breaks the chain. Your auditor can verify it themselves.