Corrective Action (CAPA) Database

Why Regulated Companies Need a CAPA Database

In regulated environments, corrective action and preventive action (CAPA) is a cornerstone of quality. The need for CAPA can be found in regulations (e.g., FDA's 21 CFR 820.100), standards (e.g., ISO 9000, ISO 13485) and guidelines (ICH Good Clinical Practice). For the purpose of compliance and to ensure the safety and quality of products, regulated companies should have a CAPA process and a CAPA database in place.

Simplifying CAPA: Seven Steps
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