Releases

Plan releases as governed bundles of modules, track each status from draft through GA, and approve the whole package against the evidence behind it — so what ships is exactly what was reviewed and signed.

This section covers planning a release, tracking its status through its lifecycle, and taking it through approval.

A release is a governed bundle, not a checkbox

In many toolchains a “release” is just a label you attach after the fact. In TraceUnified a release is a first-class, governed object: a bundle of the exact requirements, tests, risk records, architecture, SBOM, and documents that make up a shippable increment, captured together so the package can be reviewed and approved as one thing. Because the bundle references the actual records — not copies — the evidence behind a release stays live: if a test in the bundle is failing or a linked requirement went suspect, the release reflects that state honestly rather than hiding it behind a green tag.

From draft to general availability

Every release moves through a lifecycle of controlled statuses — draft while it’s being assembled, a controlled state while it’s under review, and general availability once it’s approved and shipped. Those statuses aren’t cosmetic; they gate what can change. A release under approval can’t be quietly edited out from under its reviewers, which is what lets a signature on a release mean something under 21 CFR Part 11.

Why this matters for regulated shipping

The point of treating releases this way is a guarantee auditors and quality teams care about: what shipped is exactly what was reviewed and signed. When an inspector asks “show me the evidence behind version 2.1,” the release bundle is the answer — the baselined items, the verification results, the risk posture, and the signatures, all preserved together.

What’s in this section

• Planning a release — bundling items, baselines, tests, and documents
• Statuses — draft, controlled, and general availability
• Approving a release — signing off against the evidence
• Ship a release — a step-by-step walkthrough from bundling to sign-off