Incident to CAPA, closed-loop

A corrective and preventive action lifecycle that proves its own compliance.

The problem

Corrective actions live in spreadsheets and email threads. Verification is manual, ineffective fixes quietly close, and proving compliance to an auditor means reconstructing a story after the fact.

How it works

Every record is a living instance

Each CAPA is a running process; the list of instances is your register: always current, always complete.

Roles assigned at triage

Triage routes the work to a resolver, a checker, and a quality lead, so accountability is explicit from the first step.

Verification that closes the loop

If verification finds the fix ineffective, the process reopens at root-cause analysis instead of quietly closing.

Audit-ready by construction

Because every step and decision is recorded as it happens, proving compliance is a matter of reading the history.

Dynamic role assignment

Conditional routing

Re-entry loops

Audit register

Human-in-the-loop

Outcome

A traceable register where nothing slips and verification is enforced, aligned with ISO 9001 / 13485 expectations.

ISO 9001 / 13485

aligned by design

Every CAPA

traceable in the register

Auto-reopen

on failed verification