Creating a CAPA

A CAPA record documents the full lifecycle of corrective and preventive actions taken in response to a deviation. This page covers how to create a CAPA, define its structure, and manage its content through the detail page.

What You Can Do

• Create a CAPA linked to a specific deviation.
• Document root cause analysis findings.
• Define corrective actions to address the immediate problem.
• Define preventive actions to prevent recurrence.
• Set effectiveness criteria and review due dates.
• Add AI-generated proposals for root cause analysis and action descriptions.
• Link related documents and CAPAs for cross-referencing.
• Update CAPA status through the workflow.

Creating a CAPA

From a Deviation

1. Open the deviation detail page.
2. Click Create CAPA (requires the capa.create permission).
3. The system creates a CAPA linked to the deviation and redirects you to the CAPA detail page.

From the CAPA List

1. Navigate to CAPA Management from the main navigation.
2. Click Create CAPA.
3. Fill in the CAPA creation form.
4. Submit to create the record.

Tip

When creating a CAPA from a deviation, the system automatically links the deviation and carries over relevant context. This is the recommended approach to maintain traceability.

CAPA Detail Page

The CAPA detail page provides a comprehensive view of the CAPA record organized into several sections.

Header Information

The header displays:

• CAPA title (or the linked deviation title)
• CAPA ID
• Status badge — Visual indicator of the current status
• Action buttons — Context-sensitive buttons for status updates and actions

CAPA Content

The detail page includes the following information:

Section	Description
Description	Detailed description of the CAPA scope and objectives.
Root Cause Analysis	Findings from the investigation, including AI-generated proposals.
Corrective Actions	List of actions to fix the immediate problem.
Preventive Actions	List of actions to prevent future occurrences.
Effectiveness Criteria	Measurable criteria for determining CAPA effectiveness.
Linked Deviation	Reference to the originating deviation.

AI-Generated Proposals

The system can generate AI-powered proposals for:

• Root Cause Analysis — Suggested root cause based on the deviation data.
• Action Descriptions — Proposed corrective and preventive action descriptions.

AI proposals are displayed as formatted text that can be reviewed, accepted, or modified before incorporation into the CAPA record.

Note

AI proposals are suggestions only. Always review and validate AI-generated content against your organization’s procedures and domain expertise before accepting it.

Managing CAPA Status

Updating Status

1. On the CAPA detail page, click the status update button.
2. Select the new status from the available options.
3. The system updates the status and records the change in the audit trail.

Status transitions require a confirmation dialog with an option to provide comments or evidence for the transition.

Caution

Some status transitions may require electronic signature re-authentication. If prompted, re-enter your password to confirm the status change. This is required for 21 CFR Part 11 compliance.

Adding Actions

From the CAPA detail page, you can add corrective and preventive actions:

1. In the actions section, click Add Action.
2. Specify the action type (corrective or preventive).
3. Enter the description, responsible person, and due date.
4. Save the action.

Linking Resources

The CAPA detail page supports linking to:

• Related Documents — SOPs, procedures, or work instructions affected by the CAPA.
• Related CAPAs — Other CAPA records that are connected to this investigation.

After Creating a CAPA

Once a CAPA is created, the typical workflow is:

1. Define Root Cause Analysis — Document findings from the investigation.
2. Create Actions — Define corrective and preventive actions with assignments and deadlines.
3. Track Action Completion — Monitor progress through the action management page.
4. Conduct Effectiveness Review — Verify that the CAPA successfully resolved the issue.
5. Close the CAPA — Mark as closed after a successful effectiveness review.