On 23 Aug, 21:53, douglas.mar...@GLOBALIQ.COM (Douglas Martin) wrote: > It's too much like hard work for me to actually dig up documents pointing > out the need for validating clinical reporting systems (I do know they > exist; I'm just not prepared to scrounge them up). > > However I will point out one important issue. In the absence of validation, > how to you intend to prove to chronically suspicious regulatory agencies > that what comes out of your clinical reporting system corresponds to what > goes into it? > > Someone using your system could theoretically manually check every data > item coming out with the appropriate numbers going in, but that would > quickly become VERY tedious. Hence the need for a system that can be > trusted to a very high degree, and hence the need for validation.

"Validation" does not guarantee that what comes out is always correct even if it has gone through full system life-cycle validation. So where does that leave it?