CAPA Effectiveness Review

The effectiveness review is the final phase of the CAPA lifecycle. It determines whether the corrective and preventive actions successfully addressed the original deviation. This page covers how to access, complete, and submit the review.

Prerequisites

Before conducting an effectiveness review:

• All corrective and preventive actions must have a status of Completed. The Submit Review button is disabled until this condition is met.
• You must have the capa.review permission.

Caution

If you can see the effectiveness review page but the submit button is disabled, check the Action Status Summary. All actions must be completed before you can submit a review.

Open the effectiveness review

From the action management page

1. When all actions are completed, select Start Effectiveness Review in the page header.

Directly

1. Navigate to the effectiveness review page for the CAPA.

Review the CAPA summary

The summary card displays:

• Root Cause Analysis — the identified root cause from the investigation phase.
• Effectiveness Criteria — the measurable criteria defined during CAPA creation.
• Due Date — the deadline for completing the effectiveness review, with an overdue badge if past due.

Check the action status summary

The progress dashboard shows counts of actions in each status:

Metric	Description
Pending	Actions not yet started (should be 0 for review).
In Progress	Actions currently underway (should be 0 for review).
Completed	Actions that have been finished.
Total	Total number of actions.

Note

If actions are still pending or in progress, a warning alert appears: “All corrective and preventive actions must be completed before conducting the effectiveness review.”

Complete the review form

Step 1: Determine effectiveness

Select one of two options:

• Yes - Effective — the CAPA successfully addressed the root cause and prevented recurrence.
• No - Requires Follow-up — the CAPA did not fully resolve the issue and additional actions are needed.

Step 2: Document findings

In the Review Findings field (required), describe your assessment of whether the CAPA was effective. Explain how you determined effectiveness based on the defined criteria.

Step 3: Provide evidence

In the Evidence and Data field (required), provide specific evidence, data, or metrics that support your findings. Include measurable results, observations, or documentation.

Step 4: Add recommendations (if not effective)

If you selected No - Requires Follow-up, enter Recommendations for Follow-up describing what additional actions should be taken.

Step 5: Submit the review

1. Select Submit Review (or Update Review if modifying an existing review).
2. The system records the review and updates the CAPA status.

Complete the review with electronic signature

When submitting from the CAPA list modal:

1. Enter a Conclusion with the overall conclusion of the CAPA effectiveness.
2. Enter an Assessment with a detailed assessment of implementation and results.
3. Select Submit Review.
4. In the Signature Modal, provide your electronic signature to complete the review.

Tip

The conclusion field is analyzed to determine effectiveness. Including words like “effective” or “successful” in your conclusion will automatically mark the CAPA as effective and transition it to closed status.

Review outcomes

CAPA effective

When the review determines the CAPA was effective:

• A green CAPA Effective badge is displayed.
• The CAPA status transitions to Closed.
• A success alert confirms the CAPA process is complete.
• You are redirected to the linked deviation page.

Requires follow-up

When the review determines the CAPA was not effective:

• A Requires Follow-up warning badge is displayed.
• The CAPA remains in its current status.
• A warning alert appears: “Additional actions are needed. Review the recommendations and consider creating a new CAPA or updating the existing one.”

Update an existing review

If a review has already been submitted, an informational alert shows the date and reviewer name. Modify the form fields and select Update Review. The system records the updated review and preserves the audit trail.

Permissions

Permission	Description
capa.review	Required to access the effectiveness review page and submit reviews.

Note

Users without the capa.review permission who attempt to access the effectiveness review page will see an “Access Denied” message with a link to return to the CAPA.

Practical example: effectiveness review for a data integrity CAPA

Scenario: A CAPA was created after a deviation where an operator manually overwrote electronic batch record entries without following the audit trail correction procedure. All three CAPA actions are completed: retraining on data integrity SOP, implementing system-level controls to prevent unreviewable overwrites, and conducting a retrospective review of the operator’s batch records from the past 6 months. You are the QA manager conducting the effectiveness review.

Completing the review

1. On the left sidebar, select CAPA and expand the data integrity CAPA.
2. Confirm the Progress Summary shows: Pending: 0, In Progress: 0, Completed: 3, Total: 3.
3. Select Start Effectiveness Review.
4. Review the CAPA summary:
   • Root Cause Analysis: Operator was not trained on the updated data integrity SOP (SOP-DI-004 v3). The system allowed free-text overwrites without mandatory reason codes.
   • Effectiveness Criteria: Zero unauthorized data modifications for 60 days post-implementation; 100% of operators retrained and assessed.
5. Determine effectiveness: Select Yes - Effective.
6. Enter Review Findings: “All 14 operators completed data integrity retraining and passed the assessment with scores above 90%. System controls now require a reason code selection and supervisor approval for any electronic batch record modification. Retrospective review of 47 batch records found 3 additional unauthorized overwrites, all documented and investigated as part of this CAPA. No unauthorized modifications have occurred in the 60 days since controls were implemented (monitoring period: 2026-01-05 to 2026-03-06).”
7. Enter Evidence and Data: “Training records: TR-2026-0088 through TR-2026-0101 (14 operators). System validation report: VAL-2026-0023 confirming reason code enforcement. Audit log export showing zero unauthorized overwrites from 2026-01-05 to 2026-03-06 (60-day monitoring period). Retrospective batch record review report: QA-RPT-2026-0019.”
8. Select Submit Review.
9. Provide your electronic signature when prompted.

Result

The review is marked as CAPA Effective (green badge). The CAPA status transitions to Closed and you are redirected to the linked deviation page. The complete audit trail — from deviation through root cause analysis, corrective and preventive actions, and effectiveness verification — is preserved for regulatory inspection readiness.