From: Ira Burton <ira.burton@...>
Date: 2005-05-03T22:50:10+09:00
Subject: Re: Has anyone used Ruby for validated FDA applications?

We have made similar arguments for our php based work and it has never
resulted in any sort of negative action.  We typically have a fairly
bloated test suite that we run our code against.  Auditors really like
to see that sort of thing.  They are not looking to have you prove
that there are absolutely no bugs, but rather you have made a good
faith effort to find them all.  (This obviously depends to what degree
a failure of your software can lead to a dangerous result for a
patient.)

On 5/3/05, William Morgan <wmorgan-ruby-talk@masanjin.net> wrote:
> Excerpts from Simon Crase's mail of  3 May 2005 (EDT):
> > At some point I can imagine an FDA auditor saying:"OK, your Ruby script
> > says that the code conforms to your spec.  What steps have you taken to
> > validate your script?"
> > Me "We tested with Ruby Unit"
> >
> > FDA Auditor "What steps did you take to validate Ruby Unit and the Ruby
> > interpreter?"
> >
> > Any ideas on what to say next?
> 
> What would you normally say about your trust in a third-party tool? For
> commercial software I suppose you might say, "The company that created
> this tool assures us it's correct." For open source software like
> Test::Unit, I would say something like:
> 
> a) Test::Unit has an active user and developer community, which we
>    monitor for bug reports, patches, other user's experiences, etc.
>    (i.e. "we read ruby-talk");
> b) To the best of our knowledge there are no outstanding bugs that affect
>    its ability to evaluate our code; and
> c) [Depending how thorough you need to be] We've created an ad-hoc test
>    suite of buggy code that we believe is representative of the types of
>    errors potentially present in our code, and Test::Unit successfully
>    identifies them.
> 
> --
> William <wmorgan-ruby-talk@masanjin.net>
> 
>