IT owning CSV program with little to no QA involvement

Jim Wynne said:

Part of the problem is that validation is often a self-fulfilling prophecy. The strategy should be to try to prove the hypotheses wrong, instead of the common parth of trying to prove them to be correct. Physicist Richard Feynman: "The first principle is that you must not fool yourself and you are the easiest person to fool."

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Amen. I’ve been preaching this, doing it and proving it for 40 years. Seek to challenge not confirm. In my experience when teh validation designer reports into the development organization (IT, R&D, Equipment/process/product engineering) It doesn’t take long for them buckle to a design that confirms what the organization wants them to confirm. And no matter how many disasters result, they can’t help themselves from repeating the pattern. Effective Validation isn’t easy and it takes more than a passing acquaintance with study designs to get it right.