CAPA Action Management

The CAPA Action Management page provides a dedicated view for tracking and completing all corrective and preventive actions. This page covers how to update action statuses, provide evidence, use bulk assignment, and start the effectiveness review.

Open the action management page

1. On the left sidebar, select CAPA.
2. Expand a CAPA row in the list.
3. Select an action to open the action tracking page.

The page displays the CAPA header, overview, and all actions organized by type (corrective and preventive).

Review the CAPA overview

At the top of the page, the overview card shows:

• Root Cause Analysis — summary of the identified root cause.
• Effectiveness Review — the defined effectiveness criteria and due date.
• CAPA Status — current status badge with deviation link.

Update an action status

1. On the action card, select a new status from the status dropdown.
2. Available transitions: Pending to In Progress, In Progress to Completed.

Mark an action as completed

When changing status to Completed, a completion form appears:

1. Select Completed from the status dropdown.
2. In the Evidence of Completion form that expands, enter a description of what was done.
3. Select Mark Complete.

Caution

Evidence of completion is required when marking an action as done. This documentation is essential for audit trail completeness and effectiveness review.

Re-authenticate for electronic signatures

If a signature already exists for the action, the system prompts for re-authentication:

1. Click Get Verification Code to receive a 6-digit code via email.
2. Enter the verification code in the field provided.
3. Select Re-sign to confirm the completion.

This protects the integrity of the electronic signature process in compliance with 21 CFR Part 11.

Use bulk assignment

Bulk assignment lets you reassign multiple actions to a single user at once.

1. Select Bulk Assign (available from the CAPA list expanded view).
2. In the Bulk Assignment modal, search for and select the assignee.
3. Check the boxes next to the actions you want to reassign. Each action shows its current assignee and status.
4. Select Assign Actions.

Tip

Bulk assignment is useful when a team member leaves or when redistributing workload. You can select any combination of corrective and preventive actions.

Review progress

The Progress Summary card at the bottom of the page shows:

Metric	Description
Pending	Number of actions not yet started.
In Progress	Number of actions currently being worked on.
Completed	Number of finished actions.
Total	Total number of corrective and preventive actions combined.

Start the effectiveness review

When all corrective and preventive actions are completed:

1. In the page header, select Start Effectiveness Review.
2. This navigates you to the Effectiveness Review page.

Note

The effectiveness review cannot begin until every action (both corrective and preventive) has been marked as completed. The system enforces this requirement automatically. The Start Effectiveness Review button is only visible to users with the capa.review permission.

Action fields

Each action card displays:

Field	Description
Action Number	Sequential number within the action list.
Status Badge	Current status with color coding (pending, in-progress, completed).
Overdue Badge	Red badge when the due date has passed and the action is not completed.
Description	Detailed description of what needs to be done.
Responsible Person	The user assigned to complete this action.
Due Date	Deadline for completion.
Completed Date	Shown when the action has been marked as complete.
Completion Evidence	Text describing what was done, displayed in a highlighted section.

Practical example: tracking actions for a cross-contamination CAPA

Scenario: A CAPA was created after a cross-contamination deviation where Product A residue was detected on equipment used for Product B. The CAPA has three corrective actions and one preventive action.

Updating action statuses

1. On the left sidebar, select CAPA and expand the cross-contamination CAPA.
2. The Progress Summary shows: Pending: 4, In Progress: 0, Completed: 0, Total: 4.
3. Select Action #1 (“Perform additional cleaning validation swabs on shared equipment line EQ-14”). Change its status from Pending to In Progress.

Completing an action with evidence

1. The cleaning validation is done and swab results are within acceptance criteria. On Action #1, select Completed from the status dropdown.
2. In the Evidence of Completion form, enter: “Cleaning validation swabs performed on 2026-03-12. All 12 sampling locations on EQ-14 showed residue levels below 10 ppm acceptance criterion. Swab results documented in CV-RPT-2026-0034. Most challenging location (valve manifold): 3.2 ppm.”
3. Select Mark Complete. If prompted, click Get Verification Code, enter the 6-digit code sent to your email, and confirm the electronic signature.

Using bulk assignment

The QA specialist originally assigned to Actions #2, #3, and #4 is on leave. Reassign to a colleague:

1. From the CAPA expanded view, select Bulk Assign.
2. Search for and select “qa.specialist2@company.com”.
3. Check the boxes for Actions #2, #3, and #4.
4. Select Assign Actions.

Starting the effectiveness review

1. After all four actions show Completed status (Progress Summary: Pending: 0, In Progress: 0, Completed: 4, Total: 4), the Start Effectiveness Review button becomes available.
2. Select Start Effectiveness Review to proceed to the final CAPA phase.

Permissions

Permission	Description
capa.update	Update action statuses and provide completion evidence.
capa.review	Access the effectiveness review once all actions are complete.