Automating Corrective Action and Preventive Action ( CAPA ) Processes in FDA and ISO -Regulated Environments
Implementing corrective action and preventive action systems for FDA-regulated manufacturers are a necessity to guarantee quality and ensure compliance with Current Good Manufacturing Practices CGMPCGMPof the Quality System (QS) Regulations. Replacing a paper-based CAPA system with an electronic system is challenging, not to mention connecting it with change control, training and other quality systems. The resources below explain what to look for in an electronic system and how an automated CAPA system clearly brings great benefits, not only in terms of cost savings but also in terms of product safety and effectiveness.
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