CAPA Management

Corrective Action/Preventive Action (CAPA) is the core of a sound quality management system and is central to a closed loop, continuous improvement process. Traditionally, homegrown systems, stand-alone applications, or even manual paper-based systems have managed the CAPA process at the departmental level to serve the needs of specific user groups. Such pointsolutions fail to address systemic quality problems because they lack broad enterprise reach. Companies are now recognizing the significant impact of quality control on profitability and are taking an enterprise-wide approach to automating CAPA. Companies regulated by FDA or those following standard such as ISO are leading this trend, as they have to follow external mandates on quality management and need to lower their risk of non-compliance across all operations.

MetricStream CAPA is a comprehensive solution that enables companies to streamline their CAPA processes across the enterprise. It provides end-to-end exception and change management capabilities to help companies capture problem data from anywhere in their operation, conduct investigation to determine the root cause, manage the entire preventive and corrective process, implement changes, and ensure that the problem is resolved effectively. The powerful analytics and reporting capability with graphical dashboards to track each case from initiation to closure gives managers complete real-time visibility into the quality system.