Clarix
Workflows

Deviation to CAPA Closure

Creating a deviation, linking to a root cause investigation, opening a CAPA, completing verification, and closing the record.

Deviation to CAPA Closure

This workflow walks through the complete quality event lifecycle in Clarix — from the moment a deviation is raised through root cause investigation (RCI), corrective and preventive action (CAPA), verification, and final closure. Maintaining this chain is critical for 503B GxP compliance and FDA inspection readiness.

Lifecycle overview

Step 1 — Create the deviation

Role required: Any staff (initiator), QA Officer (review)

  1. Navigate to Quality → Deviations and click New Deviation.
  2. Complete the required fields:
    • Title — concise description of the event
    • Type — Process, Equipment, Environmental, Product, Supplier, or Other
    • Severity — Critical, Major, or Minor (per your facility SOP)
    • Date and time of occurrence
    • Description — factual account of what occurred; do not speculate on cause here
  3. If the deviation was discovered during a batch step, link the batch using the Related Batch field. Clarix imports the batch number and step into the deviation record.
  4. Attach any supporting evidence (photos, instrument printouts, raw data).
  5. Save. The deviation status is Open and a notification is sent to the QA queue.

Note: For OOS lab results, navigate to Lab → OOS Results and use the Raise Deviation action directly from the OOS record. This automatically links the OOS result to the deviation.

Step 2 — Assign root cause investigation

Role required: QA Officer

  1. Open the deviation and click Assign RCI.
  2. Select the investigator and set the investigation due date per your SOP.
  3. The deviation status changes to Under Investigation.
  4. The investigator receives a task notification and can access the deviation record.

Step 3 — Complete root cause investigation

Role required: Investigator (QA Officer or designated SME)

  1. Open the assigned RCI from Quality → Root Cause Investigations.
  2. Document your investigation methodology (5-Whys, fishbone, fault tree, etc.).
  3. Identify the contributing factors and the root cause.
  4. Recommend corrective actions in the RCI findings section.
  5. Click Complete RCI. The status updates; the deviation moves to Pending CAPA.

Edge case: If investigation determines the deviation was an isolated event with no systemic cause and no corrective action is warranted, the investigator documents the justification and selects No CAPA Required before completing the RCI. This triggers the closure-without-CAPA path (see Edge Cases below).

Step 4 — Create CAPA from RCI

Role required: QA Officer

  1. From the completed RCI, click Create CAPA. Clarix pre-populates the CAPA title, linked deviation, and RCI findings.
  2. Add specific corrective action tasks:
    • Action description — what will be done
    • Owner — person responsible
    • Due date
  3. Add preventive action tasks if applicable (systemic process changes, training updates, SOP revisions).
  4. Save. CAPA status is Open.
  5. Assign the CAPA to the action owner. Status moves to In Progress.

Step 5 — Implement corrective action

Role required: CAPA Owner (as assigned)

  1. Open the CAPA from Quality → CAPAs or from the task notification.
  2. For each action item, click Mark Complete when the action is finished.
  3. Attach evidence of completion (updated SOP, training record, maintenance log, etc.).
  4. Once all actions are marked complete, click Submit for Verification.
  5. CAPA status moves to Verification.

Step 6 — CAPA verification

Role required: QA Officer (verifier)

  1. The QA Officer reviews the completed actions and attached evidence.
  2. Verify that:
    • Each action was completed as described
    • Evidence is sufficient to demonstrate effectiveness
    • The root cause is addressed and unlikely to recur
  3. If verification passes, click Verify Effective. CAPA status → Closed/Verified.
  4. If the CAPA is not yet effective (e.g., not enough time has elapsed to confirm the fix), click Re-Verification Required and set a new verification date.

Step 7 — Close deviation and CAPA

Role required: QA Officer

  1. When the CAPA is closed and verified, Clarix automatically flags the linked deviation for closure.
  2. Navigate to the deviation and click Close Deviation.
  3. Confirm that all linked RCIs and CAPAs are in a closed state.
  4. Enter a closure summary referencing the CAPA number and verification outcome.
  5. Both records are now closed and locked for editing. They remain fully accessible for audit and inspection.

Edge cases

ScenarioHow Clarix handles it
Deviation raised from a batch stepThe batch and step are automatically linked. During QA batch review, the open deviation is surfaced as a flag that must be acknowledged or resolved before the batch can be released.
OOS result triggering deviationUse the Raise Deviation action on the OOS record. The OOS is linked bidirectionally; closing the deviation without addressing the OOS is blocked.
CAPA re-verification requiredIf the initial verification finds the actions insufficient, the verifier sets a re-verification date. The CAPA returns to In Progress for additional action.
Deviation closed without CAPAWhen the RCI concludes no systemic cause exists, the investigator selects No CAPA Required with a documented justification. QA must countersign the justification. The deviation can then be closed directly from the RCI. The justification is included in the deviation record for audit.

Receiving Materials to Production

From supplier shipment through QA quarantine release and lot assignment in a batch step.

QA Review and PIC Release

Batch review from Pending QA through QA approval and PIC release to production use.

On this page

Deviation to CAPA ClosureLifecycle overviewStep 1 — Create the deviationStep 2 — Assign root cause investigationStep 3 — Complete root cause investigationStep 4 — Create CAPA from RCIStep 5 — Implement corrective actionStep 6 — CAPA verificationStep 7 — Close deviation and CAPAEdge casesRelated pages