Well, of course the answer to the question posed in the title is a clear “No”…. at least as far as the pharmaceutical and biopharmaceutical industry understands and interprets validation. So why the question?
My eye was drawn to an article over the weekend that reported on a High Court ruling that legal documents could be served on an individual via Facebook. In the case in question, the claimant stated that there were doubts raised whether the defendant actually lived at the address that court documents were originally sent to. However, his Facebook account was active and it was judged to be an authentic site belonging to the defendant. Mr. Justice Tear therefore rules that court papers could be served via Facebook.
Relevance? Well it just got me thinking about how as an industry we make strenuous efforts (most of the time!) to ensure our IT systems are developed to the highest standards and comply with finest details of validation requirements… and for good reason. But out in “the real world” the issue of validation often doesn’t really come into the discussion. Case law is often about “the balance of probability”. On the balance of probability, Facebook is probably a reliable electronic delivery mechanism and so its use was authorised. What impact would this philosophy have on the time, resources and effort we expend on development of our IT systems? Perhaps some of our regulations need a little more “real world thinking”? To use an old business saying, do we really need a Rolls Royce all of the time when perhaps a Ford Focus would suffice? Wishfull thinking????