Here’s a piece I wrote in 2008. It has generated the most interest here by far. I still actually use quite a bit of this material while giving internal training. So I thought I’d reblog it. ~TJK

T. J. Kuhn | GxP Zone

In my current role (Clinical Quality Assurance), I support groups that are involved in validating electronic systems for use within clinical trials. That is, they are conducting testing of these computer systems and generating evidence of that testing, its results, problems encountered, and the resolution of those problems.

I used the word “evidence” above very deliberately and with special meaning. The expectation of regulatory bodies (like FDA, EMEA and member agencies, Health Canada, etc.) is that the evidence that is generated in any manufacturing or research endeavor that relates to health products must be strong enough to make a case in a court of law. Furthermore, they assign the burden of proof to those making the claim. That is, they assume that a drug is unsafe, that a device is ineffective, or that data is fraudulent until it is proven otherwise. This is a new paradigm for many who work…

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