"validating" open-source software

Is there anyone out there who has used PostgreSQL to store clinical-trial
data supporting an application to the FDA for approval of a product? If
so, I would love to hear your story.

I actually don't use PostgreSQL or any database software directly; rather,
I'm posting this on behalf of the R community (in an unofficial capacity; R
is a GPL statistical programming environment, see www.r-project.org for
more info if curious). The question has been raised on the R discussion
list of what, if anything, one must do if one wants R to be the statistical
analysis engine behind a submission for FDA approval (of a drug for
instance), when the regulating agency has some requirements designed to
ensure the integrity of the electronic processes used. (I'm still learning
what the FDA's requirements are.) From my limited experience so far I know
that there are some specific requirements on database systems and the way
organizations use them, while I have yet to find any clear requirements on
analysis systems. So it occurs to me that if anyone has addressed this
topic regarding a database, where the FDA seems to focus its attention,
then dealing with analysis software ought to be a cakewalk in comparison.

Please don't feel compelled to tell me about the high quality of
open-source software; I'm already a convert. I use R professionally and
have found it to be higher quality than any other statistical package I've
ever used. Besides, we've already had those philosophical discussions on
the R discussion list. Now some of us are going about the more mundane
task of figuring out what regulations may require, if anything.

Thanks for any information,

-Jim Garrett
Becton Dickinson Diagnostic Systems
Baltimore, Maryland, USA

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