Why deviation records fail audits
- Incomplete event description lacking specificity
- No documented immediate containment actions
- Root cause not supported by evidence
- Corrective actions not linked back to root cause
- Missing follow-up and effectiveness verification
LabComplyx deviation workflow
- Structured deviation intake with event classification
- Governed AI drafting with deviation-specific guardrails
- Traceable linkage: event → root cause → action → closure
- Human review checkpoint before record finalization
- Full audit trail with tamper-evident entries