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Re: FDA-conform validation - any hints?
- From: Jim Drash <jim dot drash at gmail dot com>
- To: Jan dot Schormann at brainlab dot com, cygwin at cygwin dot com
- Date: Mon, 11 Apr 2005 14:50:31 -0400
- Subject: Re: FDA-conform validation - any hints?
- References: <firstname.lastname@example.org> <KCEOLMMHICICJKHPFOALMEAGDDAA.Jan.Schormann@BrainLAB.com>
- Reply-to: Jim Drash <jim dot drash at gmail dot com>
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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