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. A positive review closes the CAPA; a negative review triggers follow-up actions.

What You Can Do

• Evaluate CAPA effectiveness with a structured review form.
• Provide evidence and findings to support the effectiveness determination.
• Make a follow-up recommendation when the CAPA was not fully effective.
• Sign off electronically to meet regulatory requirements.
• Update existing reviews if additional information becomes available.
• Close CAPAs automatically upon a positive effectiveness determination.

Prerequisites

Before conducting an effectiveness review:

1. All actions must be completed — Every corrective and preventive action must have a status of “Completed.” The submit button is disabled until this condition is met.
2. Review permission required — Only users with the capa.review permission can access the effectiveness review page.

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.

Accessing the Effectiveness Review

There are two ways to access the review:

From the Action Management Page

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

From the Effectiveness Review Page

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

Review Page Layout

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.

Action Status Summary

A 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.”

Completing 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

Enter your Review Findings (required):

• Describe your assessment of whether the CAPA was effective.
• Explain how you determined effectiveness based on the defined criteria.

Step 3: Provide Evidence

Enter Evidence and Data (required):

• Provide specific evidence, data, or metrics that support your findings.
• Include measurable results, observations, or documentation.

Step 4: Recommendations (If Not Effective)

If you selected “No - Requires Follow-up,” an additional field appears:

• Enter Recommendations for Follow-up describing what additional actions should be taken.

Step 5: Submit the Review

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

Effectiveness Review with Electronic Signature

The effectiveness review modal (available from the CAPA list) includes an electronic signature step:

1. Fill in the Conclusion — Overall conclusion of the CAPA effectiveness.
2. Fill in the Assessment — Detailed assessment of implementation and results.
3. Click Submit Review.
4. A Signature Modal appears for electronic sign-off.
5. 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 CAPA Effective success badge is displayed.
• The CAPA status is transitioned to Closed.
• A success alert confirms: “This CAPA has been determined effective and the deviation has been successfully resolved.”
• After a short delay, 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.”

Updating an Existing Review

If a review has already been submitted, an informational alert shows:

• The date of the previous review
• The name of the reviewer

You can update the review by modifying the form fields and clicking 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.