Hi, I have been an avid user of Elsmar since 2015 yet this is my first question in the forum. I am seeking guidance from folks who have dealt with design verification and process validation. The situation is:
My product is a Class I medical device.
We have a process output that is 100% verified. We are introducing a new equipment in the process to improve the verification of the output. This equipment is a centrifuge with a range of speeds and it was determined that although the process output is 100% verified, we need to verify if design inputs for the product are still being met at the ends of the speed range.
What should be the mental model I need to create to understand how the "process validation (namely OQ)" is intersecting with the design verification aspect?
I am also looking for guidance on how to document this in the test protocol - is this design verification or process validation? The process output is 100% verified so we should not be performing process validation. Then is it just design verification driven by the introduction of a new equipment?
I would be grateful if you could also provide a resource where I could look up more information - I have looked up the GHTF guidance but haven't been able to find an answer on the intersection of design verification and process validation.
My product is a Class I medical device.
We have a process output that is 100% verified. We are introducing a new equipment in the process to improve the verification of the output. This equipment is a centrifuge with a range of speeds and it was determined that although the process output is 100% verified, we need to verify if design inputs for the product are still being met at the ends of the speed range.
What should be the mental model I need to create to understand how the "process validation (namely OQ)" is intersecting with the design verification aspect?
I am also looking for guidance on how to document this in the test protocol - is this design verification or process validation? The process output is 100% verified so we should not be performing process validation. Then is it just design verification driven by the introduction of a new equipment?
I would be grateful if you could also provide a resource where I could look up more information - I have looked up the GHTF guidance but haven't been able to find an answer on the intersection of design verification and process validation.