Corrective And Preventive Action


Corrective And Preventive Action

CAPA ist die Abkürzung für Corrective And Preventive Actions, ein Konzept aus dem Qualitätsmanagement. Der Fokus von CAPA liegt auf der systematischen Untersuchung von Diskrepanzen (z.B. Ausfall und/oder Abweichungen) und dem Versuch das wiederholte Auftreten zu verhindern (corrective action) oder das Auftreten bereits im Vorfeld zu verhindern (preventive action).

Um sicherzustellen dass Korrekturmaßnahmen und präventive Maßnahmen effektiv sind, ist eine systematische Untersuchung von Ausfallvorkommnissen oder Abweichungen essentiell wichtig. CAPA ist ein Baustein eines umfassenden Qualitätsmanagementsystems (QMS).

CAPA ist ebenfalls Bestandteil von GAMP (Good Automated Manufacturing Practice), einem Standardregelwerk für die Validierung computergestützter Systeme in der pharmazeutischen Industrie.

Siehe auch

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