Compliance checks

Beyond how well a requirement is written, there’s the question of whether it satisfies the frameworks your project develops under — FDA, ISO, IEC, and the rest. TraceUnified runs compliance checks against those frameworks during authoring, so gaps surface while you’re still writing.

Checks against your frameworks

The frameworks a project is governed by are configured organization-wide and attached to the project (see Project settings and the Compliance section). Compliance checks evaluate a requirement against the expectations of those frameworks — the attributes and relationships a compliant record is expected to have — rather than a generic rulebook. Develop under more than one standard, and the relevant checks apply together.

Compliance verification on the record

Each requirement carries a compliance verification view that shows whether it currently passes its checks. When everything’s in order you’ll see that all checks have passed; when something’s missing, the specific issues are listed so you know exactly what to address. Because this sits on the record and updates as you work, compliance stops being an end-of-project audit and becomes part of normal authoring.

Why catch it early

A requirement that quietly fails a framework expectation is expensive to fix once it’s approved, linked, and built upon. Surfacing the gap at authoring time — next to the requirement, in plain terms — is what keeps a submission from turning into a remediation project.

From checks to evidence

Passing checks aren’t just a green light; they’re part of the evidence your program accumulates. The compliance posture captured here feeds the verification, reporting, and evidence-export capabilities described in the Compliance and Reports sections, where per-record results roll up into the documents an auditor asks for.