Named users, not a shared password
Approvals go to roles. The person who signed is the person in the trail.
Electronic records
Part 11 is not a checkbox on a quote. It is unique users, re-authentication at sign-off, a manifestation of the signature, and an audit trail that cannot be quietly edited.
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Approvals go to roles. The person who signed is the person in the trail.
Documents, batches, GRNs, and CAPA closures re-authenticate. A status change is not a signature.
Who changed what, when, and why. That record is part of the object — it does not live in a log file someone deletes.