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From: "Gary R. Van Sickle" <g DOT r DOT vansickle AT worldnet DOT att DOT net>
To: <cygwin AT cygwin DOT com>
Subject: RE: FDA-conform validation - any hints?
Date: Tue, 12 Apr 2005 08:01:22 -0500
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In-reply-to: <KCEOLMMHICICJKHPFOALAEBADDAA.Jan.Schormann@BrainLAB.com>
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> -----Original Message-----
> From: cygwin-owner AT cygwin DOT com 
> [mailto:cygwin-owner AT cygwin DOT com] On Behalf Of Jan Schormann

> 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.

A lot of that depends on what the product is (i.e. what class it is).  If
it's life-sustaining and/or implantable, "enough" takes on a whole different
meaning than if it's not.

>  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 I will.
> 

Good luck.

-- 
Gary R. Van Sickle

> So long,
> 	Jan.
> 
> > -----Original Message-----
> > From: Jim Drash [mailto:jim DOT drash AT gmail DOT com]
> > Sent: Montag, 11. April 2005 20:51
> > To: Jan DOT Schormann AT brainlab DOT com; cygwin AT cygwin DOT com
> > Subject: Re: FDA-conform validation - any hints?
> >
> >
> > Jan:
> >
> > 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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