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?