System I am working with is classifying complaints on risk. If it is high risk and determine to report a CAPA is automatically initiated.
If a medwatch is received a 3500a is filled out no matter and again a CAPA is initiated.
MDR Reporting and CAPA have always been separate decisions for me in the past. I understand they can tie in together just not every time. Also reporting any medwatch received I have never done.
Thoughts?
Thanks
If a medwatch is received a 3500a is filled out no matter and again a CAPA is initiated.
MDR Reporting and CAPA have always been separate decisions for me in the past. I understand they can tie in together just not every time. Also reporting any medwatch received I have never done.
Thoughts?
Thanks
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