Creating a CAPA

A CAPA (Corrective and Preventive Action) record documents the full lifecycle of actions taken in response to a deviation. This page covers how to create a CAPA, use AI-generated proposals, add actions, and update status.

Create a CAPA from a deviation

1. On the left sidebar, select Deviations.
2. Select View on a deviation row to open the deviation detail page.
3. Select Create CAPA.
4. The system creates a CAPA linked to the deviation and redirects you to the CAPA detail page.

Tip

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

Create a CAPA from the CAPA list

1. On the left sidebar, select CAPA.
2. Select Create CAPA.
3. Complete the CAPA creation form.
4. Submit to create the record.

Review the CAPA detail page

The CAPA detail page displays the following sections:

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.

The header displays the CAPA title (or the linked deviation title), CAPA ID, status badge, and context-sensitive action buttons.

Use 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. Review, accept, or modify the content before incorporating it 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.

Update CAPA status

1. On the CAPA detail page, select 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.

Caution

Some status transitions may require electronic signature re-authentication. If prompted, click Get Verification Code, enter the 6-digit code sent to your email, and confirm the status change. This is required for 21 CFR Part 11 compliance.

Add actions to a CAPA

1. On the CAPA detail page, in the actions section, select Add Action.
2. Specify the action type (corrective or preventive).
3. Enter the description, responsible person, and due date.
4. Save the action.

Link related resources

From the CAPA detail page, link to:

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

Practical example: creating a CAPA from a water system deviation

Scenario: A deviation (DEV-2026-0203) was reported for elevated endotoxin levels in the purified water system at sampling point WS-07. The 5 Whys root cause analysis identified a biofilm buildup in a dead-leg section of the distribution loop. You need to create a CAPA to address this.

Step-by-step

1. On the left sidebar, select Deviations.
2. Select View on DEV-2026-0203 to open the deviation detail page.
3. Select Create CAPA. The system creates a linked CAPA and redirects to the CAPA detail page.
4. The CAPA is pre-populated with the deviation title and context. Update the following:
   • Description: CAPA to address elevated endotoxin levels at WS-07 caused by biofilm accumulation in the dead-leg section between valve V-12 and sampling port WS-07.
   • Root Cause Analysis: Review the AI-generated proposal. The system suggests: “Biofilm formation in the 1.2m dead-leg section where water stagnation occurs during non-production hours. Contributing factors: dead-leg length exceeds 6D guideline (current: 8.5D), and sanitization cycle does not reach adequate temperature at this point.” Accept or modify the proposal.
   • Effectiveness Criteria: Endotoxin results at WS-07 below 0.25 EU/mL for 30 consecutive days post-remediation.
5. Add corrective actions:
   • Action 1: Perform emergency hot water sanitization (80 C for 2 hours) of the affected loop section. Assign to: utilities.engineer@company.com. Due: 2026-03-10.
   • Action 2: Retrofit piping to reduce dead-leg length from 8.5D to less than 3D. Assign to: maintenance.manager@company.com. Due: 2026-04-07.
6. Add preventive actions:
   • Action 1: Update water system P&ID drawings and add dead-leg length verification to the annual water system review checklist (SOP-WTR-008). Assign to: validation.lead@company.com. Due: 2026-04-14.
7. The CAPA status changes to In Progress once the first action begins.

The deviation detail page now shows the linked CAPA ID and status, and the timeline displays both deviation and CAPA events.

CAPA workflow

After creating a CAPA, the typical workflow is:

1. Document root cause analysis findings.
2. Define corrective and preventive actions with assignments and deadlines.
3. Track action completion through the action management page.
4. Conduct an effectiveness review to verify the CAPA resolved the issue.
5. Close the CAPA after a successful effectiveness review.