I currently work in manufacturing and I see a lot of instances when a design and process needs some form of verification or validation. We use verification activities to test and confirm that product meets the specific requirements of the defined instructions. Typically we have in process checks to verify that specifications have been met during production. We validate to testing and confirm that the product meets the specific requirements of the defined instructions. Processes require validation when the results cannot be measured, or the cost of verifying is too high to justify the need for verification. For example, my company validates the environmental tests for our IVD device.

I found this article that details a process should be validated or verified and describes what it means to be “Fully Verified” or “Fully Validated.”

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