CAPA Management

The CAPA (Corrective and Preventive Action) module helps your organization systematically address root causes of deviations and prevent recurrence. CAPAs flow through a structured lifecycle: investigation, action planning, execution, and effectiveness review.

View the CAPA list

1. On the left sidebar, select CAPA.
2. Review the status distribution pie chart at the top of the page. The total CAPA count appears in the center of the chart.
3. To filter by status, select a value from the Status dropdown, or select a segment on the pie chart.
4. To navigate between pages, use the pagination controls below the table (10 items per page).

Create a CAPA

1. On the left sidebar, select CAPA.
2. Select Create CAPA in the top-right toolbar.
3. Fill in the CAPA form fields, including the linked deviation, root cause analysis, and planned actions.
4. Select Create CAPA at the bottom of the form to save.

Note

CAPAs are always linked to a deviation. You can also create a CAPA from a deviation detail page by selecting Create CAPA there.

Apply a form template

1. On the left sidebar, select CAPA.
2. Select Use Template in the top-right toolbar.
3. Choose a pre-configured template from the template selector.
4. Complete the pre-populated form and select Create CAPA.

Expand a CAPA to view details

1. On the left sidebar, select CAPA.
2. In the CAPA list table, select the expand icon on the row you want to inspect.
3. Review the expanded panel, which shows:
   • Root Cause Analysis — summary of the identified root cause.
   • CAPA Actions — list of corrective and preventive actions with status, assignee, and due date.
   • Dependency Map — visual flow diagram showing action dependencies.
   • Effectiveness Review — review status and conclusion, if completed.

Bulk-assign actions

1. On the left sidebar, select CAPA.
2. Expand the CAPA whose actions you want to reassign.
3. Select Bulk Assign Actions.
4. In the modal, select the target user and choose which actions to reassign.
5. Select Save to apply the assignments.

Conduct an effectiveness review

1. On the left sidebar, select CAPA.
2. Expand the CAPA you want to review.
3. Select Effectiveness Review.
4. In the modal, enter the review conclusion and assessment.
5. Complete the electronic signature sign-off.
6. Select Submit to finalize the review.

Export CAPA data

1. On the left sidebar, select CAPA.
2. Select Export in the top-right toolbar.
3. Choose the export format and confirm.

CAPA list table columns

Column	Description
ID	Unique CAPA identifier.
Title	CAPA title or linked deviation title.
Status	Current status badge (Draft, Open, In Progress, Closed).
Progress	Visual progress bar (0% for Open, 50% for In Progress, 100% for Closed).
Deviation	Title of the linked deviation.
Actions	Expand/collapse to view detailed CAPA information.

CAPA statuses

Status	Progress	Description
Draft	—	CAPA record has been initiated but not yet formally opened.
Open	0%	CAPA has been created. Root cause analysis and action planning may be underway.
In Progress	50%	Corrective and/or preventive actions are actively being executed.
Closed	100%	All actions are complete and the effectiveness review has been approved.

Permissions

Permission	Description
capa.create	Create new CAPA records.
capa.update	Update CAPA details and action statuses.
capa.review	Conduct effectiveness reviews.

Tip

Use the status filter together with the pie chart to quickly identify CAPAs needing attention. Select a segment on the chart or use the dropdown to filter by status.

Practical example: CAPA lifecycle for a recurring environmental monitoring excursion

Scenario: Over the past quarter, three separate deviations have been reported for viable particle count excursions in Cleanroom CR-05 during aseptic filling operations. QA decides to open a CAPA to address the systemic issue.

1. Create the CAPA

1. On the left sidebar, select CAPA.
2. Select Create CAPA.
3. Link the CAPA to the most recent deviation (DEV-2026-0187: Viable particle excursion in CR-05).
4. Enter the root cause analysis: “Three viable particle excursions in CR-05 over the past 90 days suggest a systemic contamination source. Trend analysis points to excursions occurring within 48 hours of HVAC filter changeouts, indicating possible inadequate post-maintenance air handling validation.”
5. Select Create CAPA. The CAPA is created in Open status.

2. Define actions

Expand the CAPA and add the following actions:

• Corrective Action 1: Perform smoke study and air pattern analysis in CR-05 immediately after next scheduled HVAC filter change. Assign to: facilities.engineer@company.com. Due: 2026-03-21.
• Corrective Action 2: Review and revise HVAC post-maintenance requalification protocol (SOP-FAC-022). Assign to: qa.specialist@company.com. Due: 2026-03-28.
• Preventive Action 1: Implement mandatory 4-hour settling plate exposure in CR-05 after every HVAC filter change before resuming aseptic operations. Assign to: qa.manager@company.com. Due: 2026-04-04.
• Preventive Action 2: Add trending alert rule for consecutive environmental excursions within 90 days in the same cleanroom. Assign to: qa.data.analyst@company.com. Due: 2026-04-11.

3. Track and close

1. As actions are completed, update each from Pending to In Progress to Completed, providing evidence of completion.
2. Once all actions are done, select Start Effectiveness Review.
3. After a 30-day monitoring period with no excursions, submit the effectiveness review documenting zero viable particle excursions post-implementation.
4. The CAPA transitions to Closed status.