Electronic signatures

Where a controlled state, an approval, or an acknowledgment requires sign-off, it’s enforced with an electronic signature. Signatures are the compliance spine’s second vertebra — the mechanism that makes a regulated action attributable and binding.

What makes a signature valid

A compliant electronic signature, under 21 CFR Part 11, has to be more than a click. Every signature in TraceUnified is built to satisfy the rule’s essentials:

• Attributable — the signer re-authenticates at the moment of signing, binding the signature to their identified account rather than an open session
• Meaningful — the signature records its meaning: what the signer is attesting to (authored, reviewed, approved)
• Timestamped — a trustworthy date and time is captured with it
• Bound to the record — the signature is tied to the specific record and version it was applied to, so it can’t be detached or transferred

Together these make a signature a genuine, defensible statement of responsibility.

Where signatures are required

Signatures gate the actions that matter: moving a record into a controlled state, completing an approval step, signing a regulatory document, and acknowledging a policy. Because the requirement is configured into your workflows and rules, signing happens where your process and compliance policy demand it — and can’t be skipped where they do.

The act of signing

The mechanics of applying a signature — and of building the approval chains that sequence multiple signatures — are covered in detail in Approvals & e-signatures. This article is the compliance-level view: signatures are how the platform turns “someone changed a controlled record” into “this identified person took responsibility for this change, at this time, for this stated reason.”

Recorded forever

Every signature, with its signer, timestamp, and meaning, is written to the audit trail and retained as permanent, tamper-evident evidence — which is what lets an electronic signature carry the same weight as a handwritten one.