> ## Documentation Index
> Fetch the complete documentation index at: https://docs.elevatedsignals.ai/llms.txt
> Use this file to discover all available pages before exploring further.

# Manage a CAPA

> Drive a CAPA from creation through effectiveness verification to close.

## 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.

## 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.

<Note>
  Overdue actions and CAPAs are flagged for visibility. Reopening a CAPA for correction requires an
  independent signer and a reason for change.
</Note>
