Starting point
A critical system deviation was identified in the GxP laboratory. Without formal CAPA, structured root cause analysis and demonstrable corrective actions the validated state remains at risk.
QA and authorities expect end-to-end documentation of all steps including evidence and final effectiveness check. Preventive measures must be integrated into existing SOPs.
Approach
cube one took on troubleshooting, root cause analysis and CAPA support through to successful closure.
Analysis and CAPA trigger
- Formal CAPA trigger in the quality system.
- Independent troubleshooting and root cause analysis on the affected system.
- Development of technical and process corrective actions.
Documentation and closure
- End-to-end GxP-compliant documentation of all steps including evidence.
- Active support through closure and effectiveness check.
- Work in change management, IT administration and CSV where validated state is affected.
Outcome
CAPA successfully closed
- CAPA successfully closed and approved by QA.
- System fault remediated; no repeat deviations in follow-up period.
- Complete, audit-ready documentation available.
Prevention
- Preventive measures integrated into existing SOP.
- Validated state of system restored.
- Related: DI gap assessment.
CAPA ends with effectiveness check, not with the fix.