CAPA Incident and Non-Conformance Management
Pharmaceutical, Medical Device, and BioTech companies are required to detect and react to non-conformances and ensure that appropriate actions are taken to correct and prevent future occurrences. Still, more than half of the FDA Form 483 observations and warning letters cite Corrective Action / Preventive Action (CAPA) incident management deficiencies. CAPA Incident and Non-Conformance Management address challenges including:
- CAPA Silos
- Complex Processes
- Confusion over the difference between Corrective Action and Preventive Action
- Time-consuming approval process
- Changes to the action plan mid-stream
- No means to generate metrics
- Quickly document non-conformances and record all relevant incident information.
- Automate the processes of assigning non-conformances, investigations, and corrective actions.
- Improve management of incidents and non-conformances with root cause analysis and real-time trend
- reporting on quality issues.
- Streamline compliance with FDA regulations.
- Improve brand loyalty and customer satisfaction by continuously improving quality and responding quickly to
- potential incidents.
AKA’s Corrective Action Preventive Action (CAPA) Incident Management capabilities enable you to increase control and assuredness for how your organization operates. With our solution for life sciences companies, you can generate a Corrective Action or Preventive Action request that routes through review, root cause, corrective action taken, and verification stages. This Corrective Action tracking software generates multiple reports automatically, providing an effective mechanism for tracking the source and costs of problems.
Using a systematic approach to correcting and preventing issues, measuring the outcome and continuously monitoring the system can ensure that a company is compliant, effective and efficient. And, having a well-thought-out CAPA Incident Management system can result in successful audits, fewer investigations, less product loss, better customer satisfaction, and an increase in overall operational efficiencies.