CAPA generation criteria for Medical Device
Monica Deo
1 Posts


We have recently started to take an in-depth look at our CAPA system. Our QMS currently states, “a CAPA may be generated when an issue is identified to be repetitive and systemic.”

We want to be able to quantify what repetitive and systemic means in generating a CAPA or develop a criteria. We are looking to see what criteria other members have established in their organizations.

Thanks in advance,