CAPA Management
Streamline your Corrective and Preventive Action process from identification through effectiveness verification. Integrate root cause analysis tools and track every CAPA to closure with full traceability across complaints, audits, and nonconformances.
Key Features
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Related Modules
Audit Management
Plan, execute, and track internal and external audits with configurable checklists and finding management. Generate audit reports automatically and ensure every observation is linked to corrective actions for complete regulatory traceability.
Complaint Handling
Capture, investigate, and resolve product complaints with built-in MDR vigilance and FDA MDR reporting workflows. Ensure timely regulatory reporting and link every complaint to risk assessments and CAPA actions for continuous improvement.
Risk Management
Implement a complete ISO 14971-compliant risk management process from hazard identification through post-production monitoring. Maintain living risk management files with dynamic risk matrices and automatic residual risk recalculation.