MasterControl CAPA™ and Quality Event

For a regulated FDA, EU, ISO company, it’s imperative to establish an effective corrective action/preventive action (CAPA) program to address noncompliance in a timely manner and to avoid future problems. MasterControl helps streamline the CAPA process by improving root cause detection, solution, reporting, and resolution. The result is documented, compliant evidence of quality improvement. MasterControl CAPA collects data from multiple sources, manages trends, and connects and automatically triggers sub-system processes to solve production issues.



An effective CAPA software system improves product quality and safety, increases customer satisfaction, and, more importantly, ensures compliance with global standards such as those set forth by regulatory bodies such as FDA, EU, and ISO. MasterControl CAPA connects quality events such as non-conformance, deviations, and customer complaints and automates the management of the entire CAPA process, from initiation to investigation and all the way through closure. The system allows a CAPA form to be automatically launched from another form (such as a customer complaint) in order to streamline the CAPA process and avoid human data entry errors. Management is given a continuous, real-time overview of the CAPA process, which allows decision makers to be more proactive about improving the quality system.
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