Friday, 9 August 2013

Medical Device CAPA Software

21 CFR Part 820 QSR Compliant Medical Device Corrective Actions (CAPA) Software System

Both ISO 13485 and ISO 9000 require that Medical Device companies operate a quality management system (QMS) to ensure that they meet both regulatory and customer requirements. This includes the correct management of corrective and preventive action plans (CAPA).

A process should exists to manage corrective actions and improvements in your business and supply chain. Its important that investigations into issues and potential problems are logged and tracked through to closure.

The best CAPA management solution available

CAPA Manager is a 21 CFR Part 11 compliant solution that offers powerful improvement features to address this requirement. 

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