Corrective Action / Preventive Action (CAPA) Management aims to systematically investigate root causes of non-conformities to prevent their recurrence or to prevent the occurrence. This enables you to increase control, correct and prevent issues, measure the outcome and continuously monitor the system.
With our CAPA module your company can ensure compliance, effectiveness and efficiency, increasing at the same time the global quality level thanks to the integration of the CAPA module with the AX for Pharma ERP solution.
- Fully integrated incident management - sourcing data for incidents from within your Microsoft Dynamics ERP system and tracking the cost of non-conformances.
- Comprehensive documentation of non-conformances with accurate data on incidents.
- Reduced labor requirements with the automation of the incident management process, including assigning tasks, investigations and corrective actions.
- Increased improvement of management of incidents and non-conformances through analysis of the causes, with real-time reporting on quality.
- Streamlined and better managed procedures to address FDA regulations and requirements.
- Improved quality resulting in improved customer satisfaction.
Root Cause Analysis
Source data from within your ERP system to analyze root causes. Draw from comprehensive and accurate documentation for non-conformance issues.
CAPA Planning & Approval
Benefit from full automation of the incident management process, including assigning tasks to team members and documenting investigations and corrective actions.
Automatically send approval requests through to managers.
Reporting & Charting
Get real-time reporting on quality, incidents and non-conformance issues by type, cause, etc.
Streamline and support your operating procedures to better address FDA regulations and requirements. Learn more here: CFR - Code of Federal Regulations Title 21