Business Intelligence

Enterprise-wide CAPA Management To Help Comply With FDA Requirements

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Executive Summary

With new products to market faster, customer satisfaction and compliance to FDA regulations, medical device manufacturers need to rethink their strategy for consistent, enterprise-wide compliance management. The new strategy must additionally help manufacturers increase their operational efficiency and accelerate operational performance to global standards. FDA's Quality System Inspection Technique (QSIT) is the primary inspection program for the medical device industry. The FDA views CAPA as being directly linked to all of the other subsystems and the FDA code for CAPA defined by 21 CFR 820.100 requires strict control and management of these corrective and preventive actions.

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