Compliance

Compliance in TraceUnified is not a separate mode you switch on — controlled states, electronic signatures, and a tamper-evident audit trail run through every module. The evidence an auditor asks for is a by-product of the work, captured as you go and aligned to the frameworks you develop under.

This section explains the compliance spine: how states are controlled, how signatures work, what the audit trail records, the frameworks supported, and how readiness is verified.

Compliance as a spine, not a mode

The defining choice in TraceUnified is that compliance isn’t a feature you enable — it’s structural. Controlled states, electronic signatures, and a tamper-evident audit trail run through every module, so the evidence an auditor asks for accumulates as a by-product of ordinary work. There’s no separate “audit mode” to switch on before an inspection and no reconciliation between how you work and how you prove you worked; they’re the same activity.

How the pieces fit

Controlled states and workflows govern how a record is allowed to move — what can change, when, and who can change it — so a record under review can’t be quietly altered. Electronic signatures enforce accountability at each gate under the Part 11 model. The audit trail captures every change as a tamper-evident record. Together these three are the mechanism that makes a signature meaningful and a history trustworthy.

Framework alignment and proving readiness

Above that spine sits alignment to the frameworks you actually develop under — FDA, ISO, IEC, and EU expectations — so the controls map to specific obligations rather than a generic notion of “compliance.” Verification and quality analysis then let you prove readiness on demand: rather than preparing for an audit, you check the system’s current state and produce the signed evidence directly from the live records.

What’s in this section

• Controlled states & workflows — governing how records move
• Electronic signatures — the Part 11 signing model
• The audit trail — the tamper-evident record
• Frameworks — FDA, ISO, IEC, and EU alignment
• Verification & quality analysis — proving readiness
• Verify compliance & produce evidence — a step-by-step walkthrough from framework to signed evidence