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The CAPA Register

All CAPAs are listed with type (Corrective/Preventive), status, priority, linked deviations, and assigned owners. CAPAs close the loop on deviations — without effective CAPAs, the same problems recur, and regulators specifically audit CAPA effectiveness (it’s often the first thing they check). Focus on overdue CAPAs and those pending effectiveness verification; link every CAPA back to its source deviation for traceability.

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Work the CAPA

  1. Create a CAPA (typically linked from a deviation disposition). Write action descriptions that can be verified later, and keep due dates aligned with the risk level and product impact.
  2. Add corrective/preventive actions with owners and evidence.
  3. Complete each action with an evidence note (audit-logged, reason required).
  4. Move the CAPA to done once all actions are complete.
  5. An independent approver verifies effectiveness (signed) — this is blocked until actions are complete. A CAPA that is implemented but never verified is incomplete evidence in an inspection; use effectiveness review dates to plan follow-up sampling, trend checks, retraining confirmation, or process monitoring.
  6. Close the CAPA (signed) — blocked until effectiveness is verified.
Overdue actions and CAPAs are flagged for visibility. Reopening a CAPA for correction requires an independent signer and a reason for change.