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  • Viraj D replied to the topic Validate or Not in the forum Device Documentation 8 years ago

    As with each process validation, there should be an SOP for which any employee dealing with the validation should be trained to. Additionally, the validation depends on what type of medical device your company is producing, and it would depend on the the specification that was not verified, so it is now being validated. As Dr. Simon also mentioned in his lecture, performing 100% verification can be costly or can damaged the produced instrument. In most cases, the general validations include testing for sterilization, clean room ambient conditions, humidity/environmental testing, sterile package sealing, etc.