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.

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