CAPA Effectiveness Review

The effectiveness review is the final phase of the CAPA lifecycle. It determines whether the actions successfully addressed the original deviation. The review is filed on the CAPA record itself — there is no separate effectiveness review page. This page covers how to reach, complete, and sign the review.

Prerequisites

Before conducting an effectiveness review:

• The CAPA must have at least one action, and every action must be Completed.
• You must have QA or administrator authority (the capa.review permission).

Open the effectiveness review

1. On the left sidebar, select CAPA and open the CAPA record.
2. Once every action is complete (and no review has been filed yet), the Now panel at the top of the record becomes the effectiveness review form. Until then, the panel shows the action list and how many actions remain.

Note

If actions are still open, the review is unavailable and the record says why — for example, “2 action(s) still open — complete them before closing the CAPA as effective.” Controls you cannot use are shown disabled with the reason, not hidden.

Complete the review form

Step 1: Determine effectiveness

Choose the review outcome: whether the CAPA was effective or not effective. Every consequence of the review — whether a signature is required, whether the CAPA closes — follows from this selection.

Step 2: Document findings

In the 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 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 the outcome is not effective, recommendations for follow-up are required: describe what additional actions should be taken. The form cannot be submitted without them.

Step 5: Sign an effective closure

Closing a CAPA as effective is a binding electronic signature under 21 CFR Part 11:

1. Select Sign & close CAPA — the primary action when the outcome is effective.
2. In the signing dialog, request a verification code. A six-digit code is emailed to you.
3. Enter the code and confirm. The review, your signature, and the closure are recorded together — the CAPA is not closed until the code is confirmed.

A not effective outcome is recorded with Record review instead — it does not close the CAPA and needs no verification code.

Review outcomes

CAPA effective

• The CAPA transitions to Closed. Its actions and attachments are locked until it is reopened.
• The signature is recorded in the audit trail.
• The filed review appears in the record’s Effectiveness section and in the Now panel’s closing summary.

Not effective — requires follow-up

• The CAPA returns to follow-up: the Now panel goes back to the action list, flags that the review found the CAPA not effective, and shows the review’s recommendations.
• Add the actions the review calls for and work them to completion; the review cycle then repeats.

Amend a filed review

A filed review can be amended by QA or an administrator while the CAPA is not closed and every action is complete — the amendment form starts from what was recorded, and the audit trail preserves both versions. A closed CAPA must be reopened before its review can be amended.

Permissions

Permission	Description
capa.review	Required to file or amend an effectiveness review. Held by QA and administrators.

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 open the data integrity CAPA.
2. With all three actions complete, the Now panel shows the effectiveness review form.
3. Choose the outcome: effective.
4. Enter your 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).”
5. Enter the evidence: “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.”
6. Select Sign & close CAPA, request the six-digit verification code emailed to you, enter it, and confirm.

Result

The CAPA closes as effective and the signature is recorded in the audit trail. The complete history — from deviation through root cause analysis, actions, and effectiveness verification — is preserved on the record for regulatory inspection readiness.