Message-Id: <200504121258.j3CCwu1K009286@delorie.com> Mailing-List: contact cygwin-help@cygwin.com; run by ezmlm List-Subscribe: List-Archive: List-Post: List-Help: , Sender: cygwin-owner@cygwin.com Mail-Followup-To: cygwin@cygwin.com Delivered-To: mailing list cygwin@cygwin.com From: "Gary R. Van Sickle" To: Subject: RE: FDA-conform validation - any hints? Date: Tue, 12 Apr 2005 08:01:22 -0500 MIME-Version: 1.0 Content-Type: text/plain; charset="us-ascii" Content-Transfer-Encoding: 7bit In-reply-to: X-IsSubscribed: yes > -----Original Message----- > From: cygwin-owner@cygwin.com > [mailto:cygwin-owner@cygwin.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.drash@gmail.com] > > Sent: Montag, 11. April 2005 20:51 > > To: Jan.Schormann@brainlab.com; cygwin@cygwin.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. > > > > > > -- > Unsubscribe info: http://cygwin.com/ml/#unsubscribe-simple > Problem reports: http://cygwin.com/problems.html > Documentation: http://cygwin.com/docs.html > FAQ: http://cygwin.com/faq/ > -- Unsubscribe info: http://cygwin.com/ml/#unsubscribe-simple Problem reports: http://cygwin.com/problems.html Documentation: http://cygwin.com/docs.html FAQ: http://cygwin.com/faq/