Corrective and Preventive Action (CAPA) Management

Corrective Action and Preventive Action (CAPA) management is one of the most daunting tasks of any quality-minded organization. FDA, ISO, EMEA, and other regulations and standards mandate a systematic approach to managing corrective and preventive actions.
While all organizations hope to avoid the root causes that necessitate corrective actions, reality dictates otherwise.  Because defects, deviations, or any other gaps that trigger the need for a CAPA can come from a myriad of sources (documents, training, products, etc.), CAPA management has become the core process of a well-established compliance and quality program.

The eQCM CAPA™ module is an integral part of the eQCM quality management suite. It may be used as a stand-alone module in small organizations or integrated with other processes such as nonconformances, audits, training, complaints and others. The eQCM CAPA™ module allows organizations to create a single configurable workflow to handle the entire lifecycle of the CAPA from the triggers that can auto-launch the corrective action to the final sign-off.  If your company prefers, multiple workflows can be developed also – without vendor or IT support.

Business Applications :

• Corrective Action Management (for all types of sources including documents, products, services, supplier products, equipment, instruments, etc.)
• Preventive Action Management
• Suggestion and Enhancement Requests
• Problem management
• Anomalies management
• Change management
• General Action item tracking

eQCM CAPA™ Value Proposition :