Gartner Research

CAPA: A Platform for Top-Down Quality Management

Published: 11 April 2002

ID: G00186891

Analyst(s): Kathia Desronvil, Roddy Martin

Summary

Increased FDA pressures are forcing regulated life sciences companies to take a proactive and automated approach to their corrective action management strategies. Companies are now required to have a comprehensive integrated quality management strategy in place that encompasses the maze of quality management islands across all areas of manufacturing operations. Traditionally, companies have been reactive in developing a systematic process/plan to address nonconformance to FDA regulations, which has largely been based on the validation of cGMP systems. 30% to 50% of all 483 citations are related to CAPA.

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