Part 11 enforcement

The approval features exist to satisfy a specific standard: 21 CFR Part 11, the FDA’s rule for electronic records and electronic signatures. Rather than treating Part 11 as a checklist applied afterward, TraceUnified builds its requirements into how signing works.

Attributable signatures

Part 11 requires that a signature be uniquely attributable to one individual. Signing requires re-authentication at the moment it happens, binding the signature to the signer’s identified account — not to a shared login or an unattended session. There’s no anonymous or borrowed signature: every one points to a specific person.

The required signature components

A compliant signature has to show the signer’s name, the date and time, and the meaning of the signing. Every signature captures exactly these — who, when, and what it means — so each one is a complete, self-explaining statement of responsibility rather than a bare mark.

Binding signature to record

Part 11 requires that signatures be linked to their records so they can’t be cut, copied, or transferred to falsify a record. Signatures here are bound to the specific record — and the specific version — they were applied to. An approval can’t be detached from what was approved, and changing the record after signing doesn’t carry the signature forward; it triggers re-verification instead.

Tamper-evident and enduring

Signed records and the actions around them are written to a tamper-evident audit trail that can’t be edited or deleted, and they’re retained for the long term. This is what lets an electronic signature stand in for a handwritten one under the rule: the evidence that a signing happened — and that nothing has altered it since — endures.

Enforced, not optional

These controls aren’t conventions a user can skip. Where your process and compliance policy require a signature — to move a record into a controlled state, to approve a release — the platform enforces it, and the configuration of those requirements is locked by policy rather than left to individual discretion. The broader compliance picture this fits into is covered in the Compliance section.