CAPA Action Management

The CAPA Action Management page provides a dedicated view for tracking and completing all corrective and preventive actions associated with a CAPA. It includes progress monitoring, evidence collection, bulk assignment, and a clear path to the effectiveness review.

What You Can Do

• View all CAPA actions organized by type (corrective vs. preventive).
• Update action status from pending to in-progress or completed.
• Provide completion evidence when marking actions as done.
• Monitor progress through a summary dashboard.
• Bulk assign actions to a single user.
• Navigate to the effectiveness review when all actions are complete.

Accessing Action Management

1. Navigate to CAPA Management from the main navigation.
2. Expand a CAPA row and click on an action, or navigate to the CAPA actions page directly.
3. The action tracking page displays the CAPA header, overview, and all actions.

CAPA Overview Section

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

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

Corrective Actions

Corrective actions address the immediate problem identified in the deviation. Each action displays:

Field	Description
Action Number	Sequential number within the corrective actions 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.

Preventive Actions

Preventive actions prevent similar deviations from occurring in the future. They follow the same structure as corrective actions and are displayed in a separate section.

Updating Action Status

Changing Status

1. Locate the action you want to update.
2. Use the status dropdown on the action card to change status.
3. Available transitions: Pending to In Progress, In Progress to Completed.

Marking an Action as Completed

When changing status to Completed, a completion form appears:

1. Select “Completed” from the status dropdown.
2. The Evidence of Completion form expands.
3. Enter a description of what was done to complete the action.
4. Click 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.

Password Re-entry for Signatures

In some cases, completing an action requires re-authentication:

1. If a signature already exists for the action, you are prompted to re-enter your password.
2. Enter your password in the field provided.
3. Click Re-sign to confirm the completion.

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

Bulk Assignment

The Bulk Assignment feature allows you to assign multiple actions to a single user at once.

Using Bulk Assignment

1. Click the Bulk Assign button (available from the CAPA list expanded view).
2. The Bulk Assignment modal appears.
3. Select a User — Use the user search to find and select the assignee.
4. Select Actions — Check the boxes next to the actions you want to reassign. Each action shows its current assignee and status.
5. Click 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.

Progress Summary

The Progress Summary card at the bottom of the page provides a quick overview:

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.

Starting the Effectiveness Review

When all corrective and preventive actions are completed:

1. A Start Effectiveness Review button appears in the page header.
2. This button is only visible to users with the capa.review permission.
3. Clicking it 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.

Permissions

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