Recent Webinar Q&A on Design Verification and Design Validation:

QUES: About design verification and design validation : You have mentioned activities both on design verification and design validation : for instance shelf life, biocompatibility… We have difficulties to understand clearly what activities are design verification and what activities are design validation. Could you please explain us? Does a type of activity can be on both and so what are the differences? 

ANS:  Your company needs to specifically define these terms in an SOP so they can be followed by those using the SOP and simultaneously comply with the CGMPs upon which the SOP is based.  E.g., if I have a medical device that touches the patient, I might have requirements for functionality, biocompatibility, sterility, safety in shipping, etc.

I test each requirement, e.g.,  biocompatibility at a lab per ISO 10993, sterility per applicable ISO standard by a contract lab, do shake / drop / cross country shipping testing, environmental test, packaging seal testing (pull, dye…), functional testing (in-house bench testing, lab testing), etc.  Per my “working definitions” of V&V, I would define each of those tests of a specific requirement as a verification. Put their final versions (of verifications) altogether into a Test Report, and that would by my device Validation Test Report, proving all “user needs”, i.e., requirements (customer requirements, standards, guidance documents, manufacturing capabilities, etc.), have been met.

-- jel@jelincoln.com

Minor additional explanations on V&V added, 12/31/23 - JEL