Verify compliance & produce evidence

An end-to-end walkthrough — confirm the framework, run verification, resolve the issues it finds, and produce signed evidence for an audit.

Compliance in TraceUnified isn’t a separate binder you assemble at the end — it’s a continuous read on whether the work meets your frameworks, with the evidence already in place. This guide runs that check and turns it into something you can hand to an auditor. For the concepts behind each step, see Frameworks, Verification & quality analysis, and The audit trail.

Confirm the framework

Before you start Open the Compliance module. Know which standard the project must meet — FDA, ISO, IEC, or your own.

  1. Confirm the frameworks attached to the project, and the compliance profile that maps your work to them.
  2. Check that the modules in scope — requirements, risk, tests, training — are covered by the profile.

Result The project is measured against the right standard, so verification checks what actually matters for your submission. See Frameworks.

Run verification

  1. Run verification across the project.
  2. Review the results: Coverage against the framework, open Issues, and Gaps — requirements without tests, hazards without controls, items missing signatures.
  3. Look at the specific findings — orphaned items with no links, and suspect links awaiting re-verification.

Result A clear, current picture of where the project stands against its framework, and exactly what's incomplete.

Resolve the issues

Before you start Work from the issue list so nothing is missed.

  1. Open each issue and address its root cause — create the missing link, run the missing test, complete the missing signature.
  2. Use comments on an issue to record decisions or assign follow-up.
  3. Re-run verification to confirm the issue is cleared.

Result Issues are closed against live work rather than annotated on a checklist, and the audit trail shows what was found and how it was resolved.

Produce signed evidence

  1. Generate the compliance evidence — the coverage, verification results, and audit trail — as a report (see Build & run a report).
  2. Run it against the release or baseline you're certifying, so the evidence is fixed to a known state.
  3. Where the evidence document itself must be controlled, sign it with an electronic signature (see Electronic signatures).

Result A signed, point-in-time evidence package an auditor can rely on — produced from the system of record, not reconstructed by hand.

Note Because the audit trail is a by-product of the work, the evidence reflects what actually happened — who changed what, when, and why — not a narrative written after the fact. See The audit trail.

Where to go next

To watch coverage, quality, and compliance signals live, see Build a dashboard.

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