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).
5. The Title column header is sortable – select it to sort by title, and again to reverse the direction.

You can also search by a legacy CAPA’s displayed number (for example “CAPA-14”) even if it predates real CAPA numbering – the search matches the number shown on screen, not just the stored value.

Save a filtered view

If you find yourself setting the same search text and filters every time you open the register, save them as a named view instead of rebuilding them.

1. On the left sidebar, select CAPA.
2. Set the search text and filters you want to save.
3. Select Views in the toolbar, then select Save current view….
4. Enter a name and select Save.

To reapply a saved view, select Views and choose it from the list – the search text and every filter it was saved with are restored together. To remove one you no longer need, select the trash icon next to it in the list.

Note

Saved views are personal: only you see the views you save, on any device you sign in from. There is currently no way to share a view with the rest of your team.

Create a CAPA

1. On the left sidebar, select CAPA.
2. Select Raise CAPA in the top-right toolbar. The CAPA creation page opens.
3. Choose the deviation this CAPA addresses and document the root cause analysis. Supporting evidence and related records can be linked on the same form.
4. Select Create CAPA at the bottom of the form to save.

Note

A CAPA is normally linked to a deviation (or, in template-driven flows, a document). A standalone CAPA – one with no linked record – is allowed, but then a source is required (for example “Internal observation”, “Management review”, “Trend analysis”, “External audit”) so the CAPA stays traceable; the system refuses a CAPA with neither a link nor a source. The fastest route is from a deviation detail page: selecting Create CAPA there creates the CAPA with the deviation already linked.

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.

Propose an SOP update from a CAPA

Once a CAPA has established what went wrong and what needs to change, the Improvements tab on the CAPA record can turn that into an AI-drafted document change – either an update to a linked SOP, or a brand-new SOP if the CAPA has no linked document yet.

1. Open the CAPA record and select the Improvements tab.
2. Select the action button:
   • Propose an improved version – shown when the CAPA is linked to a document. The AI assistant reads the CAPA’s findings and the current document, and proposes specific edits.
   • Generate a new SOP – shown when the CAPA has no linked document. The AI assistant drafts a complete new SOP from the CAPA’s findings.
3. Review the proposed changes in the dialog that opens. Every proposal is clearly marked AI-GENERATED DRAFT – in the dialog and in the resulting PDF – so it is never mistaken for a human-authored change.
4. Select Approve to accept the proposal. This creates a new document version (or a brand-new document, in draft status) and links it to the CAPA.
5. The new draft still goes through the normal document approval workflow – including any required electronic signatures – before it becomes effective. Approving the AI proposal does not skip that process.

Note

Only users with capa.update permission (Admin, QA_Team with review/admin authority) can generate or approve an SOP proposal. A plain User or Auditor does not see the action.

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.

Discard a CAPA raised in error

An administrator can discard a single draft CAPA from its own page.

1. Open the CAPA.
2. Select the More actions menu (⋯) in the record header, then Discard. When the CAPA cannot be discarded, the entry is greyed out and says why.
3. Enter a reason for discarding (required) and select Discard CAPA.

Only draft CAPAs that have not been approved, that carry no active electronic signature on the CAPA or any of its actions, and that no other record cites (a change request, audit finding, SCAR, complaint or training assignment) can be discarded. Discarding is not a permanent delete: the CAPA stays in the system with its actions, history and audit trail, marked Discarded with your name, the time and your reason, and a “discard” entry is written to its audit trail. It drops out of the CAPA list and out of every dashboard and analytics total; filter by the status discarded to find it again. To discard several draft CAPAs at once, see Bulk operations.

A discarded CAPA is read-only. Its fields, actions and effectiveness review can no longer be changed, and no signature can be requested or recorded against it or its actions. Any such change is refused with the message “This CAPA has been discarded and is read-only.” A discarded CAPA also cannot be linked to a change request, complaint, SCAR, audit finding or training assignment, and its open actions leave the assignees’ task lists, the calendar and overdue reminders.

Signature requests still waiting on the CAPA or its actions when it is discarded are cancelled at the same time, so they leave the recipients’ task lists; the request page shows Cancelled — the record was discarded.

The Discard entry appears only for administrators.

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.

Choose and reorder columns

Select Columns in the toolbar to choose which optional columns are shown and in what order. Tick a column to show it, untick to hide it, and press Alt + Up/Down arrow on a focused column to reorder — the table follows the order in the menu. Identity columns are always shown. Your choice is saved per user, so it persists across sessions.

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 confirmed the CAPA was effective.
Requires Follow-up	–	The effectiveness review found the actions were not fully effective. The CAPA needs additional work and can be reopened to Open or In Progress.
Discarded	–	The draft was discarded by an administrator because it was raised in error. The record is kept, read-only, with the reason.

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 worked, move each through its named transitions — Start work, then Complete & sign, providing evidence of completion with the electronic signature.
2. Once all actions are done, the record’s Now panel becomes the effectiveness review form.
3. After a 30-day monitoring period with no excursions, file the review documenting zero viable particle excursions post-implementation and select Sign & close CAPA.
4. The CAPA transitions to Closed status.