Approvals & e-signatures

Approval chains define exactly who must sign and in what order. Each gate is enforced with 21 CFR Part 11 electronic signatures and a complete signature history, so a record only advances once the people accountable have signed.

This section covers configuring approval chains, signing and rejecting, reading the signature history, and the Part 11 controls behind it all.

Why enforced signatures change what an approval means

An approval is only as trustworthy as the control behind it. A checkbox anyone can tick, or a name typed into a field, proves nothing to an auditor. TraceUnified enforces approvals with 21 CFR Part 11 electronic signatures: the signer re-authenticates at the moment of signing, the signature is bound to the exact version of the record and the reason for signing, and the whole event is written to a tamper-evident history. That is the difference between a workflow that merely records who clicked and one that produces evidence a regulator will accept.

Chains define who signs, and in what order

Real sign-off is rarely one person. An approval chain lets you define the full signing path — author, then quality, then a regulatory approver, for example — and the order it must follow. A record can’t jump a gate or advance on a partial set of signatures; it moves only when each required signer has acted. Rules on the chain let you match the signing path to the kind of record and the stakes involved, so a minor change and a design freeze can follow appropriately different paths.

The signature history is the durable record

Every signature, rejection, and re-submission accumulates into a complete signing history attached to the record. When an inspector asks who approved a document, on what version, and when, the answer is already assembled — and because it’s tamper-evident, it stands as evidence rather than as a claim you then have to substantiate.

What’s in this section

• Approval chains & rules — defining the signing path
• Signing & rejecting — acting on an approval gate
• Signature history — the complete signing record
• Part 11 enforcement — what the electronic signature guarantees
• Sign an approval — a step-by-step walkthrough through an electronic signature gate