Built on root cause, not symptoms
Every CAPA is grounded in a documented root cause analysis, so the same finding isn't reopened at the next audit.
What's included
What goes into CAPA management
- Every finding logged into a central CAPA tracker at the point it's identified, whether it comes from a site audit, vendor audit, process audit, or inspection
- Findings routed to root cause analysis before a corrective action is defined, so the action addresses the actual cause
- Corrective actions paired with preventive actions where the finding indicates a broader process risk, not just a fix to the single instance
- Owners, due dates, and status tracked through to completion, with overdue CAPAs escalated rather than left open indefinitely
- Closure only granted after a documented effectiveness check confirms the action actually resolved the issue
Closed with evidence
No CAPA is marked closed without a documented effectiveness check confirming the corrective action held.