Controlled states & workflows

How records are governed — controlled states, gated transitions, and separation of duties run through every module.

Compliance in TraceUnified isn’t a separate module you visit — it’s a spine that runs through everything. The first vertebra is controlled states: the workflows that govern how records move and which states freeze a record and require a signature to reach.

Workflows govern movement

Every governed record moves through a workflow of states and transitions, configured for your process. The workflow decides which moves are allowed, in what order, and what must be true to make them. This is what turns a collection of records into a controlled system: nothing advances by accident, and the path from draft to approved is defined rather than improvised.

Controlled states

Certain states are designated controlled — typically the approved and released states. Reaching a controlled state can require an electronic signature, and a record in a controlled state is frozen: it can’t be quietly edited, only superseded by a new version. This is the mechanism that makes an approved record trustworthy — what was signed stays exactly as it was signed.

Who can transition

Transitions are gated by role, so the workflow enforces separation of duties. The person who authors a record may not be the one who approves it; the move into a controlled state can be reserved for a quality role. Building this into the workflow means the segregation a regulator expects is structural, not a matter of people remembering the rules.

One spine, every module

The same controlled-state model applies across requirements, risks, tests, architecture, releases, and documents. That consistency is the point: an auditor doesn’t have to learn a different governance story for each module, because they all move through controlled workflows the same way. The states, transitions, and signature requirements are configured in Administration; this section explains what they mean for compliance.

What rests on it

Controlled states are the foundation the rest of the compliance spine builds on — the electronic signatures that gate them, and the audit trail that records every move through them.

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