CAPA Management

Abstract: 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.