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RE: FDA-conform validation - any hints?
- From: "Jan Schormann" <Jan dot Schormann at BrainLAB dot com>
- To: <cygwin at cygwin dot com>
- Date: Tue, 12 Apr 2005 12:21:39 +0200
- Subject: RE: FDA-conform validation - any hints?
- Reply-to: <Jan dot Schormann at BrainLAB dot com>
Jim and Gary,
thanks for your hints. Maybe I'm unnecessarily nervous.
I'm still working on a good definition for "enough"
testing around the intended use, and to what level of
detail the intended use needs to be described. With
your comments, I'm more confidently facing the FDA-
challenge now with what we have. Now I'm curious on
the auditor's feedback - only a few weeks left :-)
Not to forget: Many thanks for the effort to all of you
who make this tool, Cygwin, working. It's not so easy to
make my company give something in return, but one day
> -----Original Message-----
> From: Jim Drash [mailto:firstname.lastname@example.org]
> Sent: Montag, 11. April 2005 20:51
> To: Jan.Schormann@brainlab.com; email@example.com
> Subject: Re: FDA-conform validation - any hints?
> I work for a very large FDA-regulated company. Our FDA IT
> audits have
> been centered on having documented processess and
> appropriate sets of
> test protocols to show compliance to those processes.
> Your validation efforts around GNU tools must describe
> what is your
> intended use and how you would test that. Please note
> that this is
> around your use of a given piece of software not anyone elses.
> So given that you are using some GNU tool as part of your process,
> then you the to have the proper work instructions and
> scope statements
> around your use of the tool.
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