CAPA Process Improvements for Medical Devices

Errors are usually a part of any process, action, or activity. There is always a percentage of error that happens. The practice must be to refine it and bring the errors down as low as humanly possible.  

To adhere with industry regulations and to remain compliant with various policies, quality processes of organizations have multiple checks and internal policies in place to address the non-compliances and errors that occur during the lifecycle of manufacturing a product. The focus of these processes is to address the errors, analyze them, fix them and ensure that they do not occur again.  

Often during this process, the regulatory burden makes it difficult for quality process individuals to provide their complete focus to solving the errors in a way that they are traceable backward, permanently fixed, and provide insights about any matters that need to be addressed immediately. 

One of the most talked-about and feared issues in a quality process is the CAPA. Corrective Action and Preventive action is in fact an opportunity for improvements in the quality processes. Read More.


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