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Corrective and Preventive Actions address identified root causes and reduce the chance that quality problems recur. CAPA records connect accountable action planning with effectiveness review.

CAPA Register

All CAPAs are shown with type (Corrective or Preventive), status, priority, linked deviations, and assigned owners. Focus on overdue CAPAs and work awaiting effectiveness verification, and preserve the source-deviation relationship where applicable.

Action Planning

CAPA detail pages show the action plan, responsible owner, due dates, status, and linked deviation context. Write actions so their completion can be verified, assign clear owners, and align due dates with risk and product impact. Completing an action requires an evidence note, and the change is recorded in the audit trail.

Effectiveness and Closure

Effectiveness dates identify when QA should verify whether the implemented action achieved its intended result. Effectiveness verification requires an independent approver and is blocked until the actions are complete. Final closure is also signed and is blocked until effectiveness is verified.
A completed CAPA can be reopened for correction only with an independent signer and a reason for change. Preserve the original decision trail when adding corrective follow-up.
For the end-to-end procedure, see Manage a CAPA.