CAPA

Run corrective and preventive actions through investigation, action, and a required effectiveness check before closure. CAPAs can be created automatically from a complaint, a nonconformance, or an audit finding — pre-filled from the source so nothing is re-keyed.

The lifecycle (Open → Investigation → Effectiveness Check → Closed) has two electronic-signature gates: action-plan approval and effectiveness-verified closure. Closure is QA-only and QA independence is the control — an approver cannot close a CAPA. By default the effectiveness check is signed by someone other than the person who carried the actions out, either the owner of an action or whoever marked it Done; where nobody else is available the same person may still sign, but the reason is required and is kept with the record. Closure is blocked until a substantive effectiveness result is recorded, or a documented reason why verification is not being performed.

• ✓ Auto-created and pre-filled from complaints, NCRs, and audit findings
• ✓ Mandatory effectiveness verification before closure, signed by default by someone other than the implementer
• ✓ Two-signature control with segregation of duties
• ✓ Bidirectional links back to the originating record