On Thu, Jul 30, 2009 at 08:49:41AM +0200, Eric Keller wrote:
> Hi everyone,
>
> I would like to introduce Subversion in our company processes... We are in
> the medical business and to sell our devices on the US market, we need the
> FDA approval. For getting this approval, we need to certify the software we
> are using. As subversion could be part of them I have to convince our BU
> that FDA clearance will not be delayed because of using an open source
> project!
> Anyway, I would be more than happy if someone in this mailing list also use
> subversion and gets its product through FDA inspection successfully.
> Feedback appreciated!
Forwarding a reply by Nico Schellingerhout with his permission.
===========================
Hi Stefan,
What is required, is that every tool that is used in the production of
software for medical devices is validated as suitable for its intended
use. Validation is a relatively light-weight task: you specify what you
intend to use Subversion for, you assess the risk to the product due to
possible failure of Subversion (this is usually a minor risk, because
Subversion does not keep the final results, but only "design" as it
were, and the risk is mitigated by the fact that the product itself will
be tested/validated before release to the field), you design a
validation test specification (this can be quite light-weight, we have a
test spec that can be executed in a few hours), and you test Subversion
following the test specification.
This is not particularly more difficult for an open source tool or a
version control tool. There are other tools that require much more
stringent testing (for example, defect tracking systems).
Cheers,
Nico
> -----Original Message-----
> From: Stefan Sperling
> Sent: 2009 Jul 30 11:43 AM
> To: Schellingerhout, Nico
> Subject: [keller.eric_at_gmail.com: [FDA] approval]
>
> Hey Nico,
>
> maybe you can provide advice for the question below?
>
> Stefan
>
> ----- Forwarded message from Eric Keller <keller.eric_at_gmail.com> -----
>
> Date: Thu, 30 Jul 2009 08:49:41 +0200
> From: Eric Keller <keller.eric_at_gmail.com>
> To: users_at_subversion.tigris.org
> Message-ID:
> <8bf961ff0907292349v5fe3d5edyca8b1b22b45c8329_at_mail.gmail.com>
> Subject: [FDA] approval
> Content-Type: multipart/alternative;
> boundary="----=_Part_4663_19195071.1248937304336"
>
> Hi everyone,
>
> I would like to introduce Subversion in our company processes... We are
> in
> the medical business and to sell our devices on the US market, we need
> the
> FDA approval. For getting this approval, we need to certify the
> software we
> are using. As subversion could be part of them I have to convince our
> BU
> that FDA clearance will not be delayed because of using an open source
> project!
> Anyway, I would be more than happy if someone in this mailing list also
> use
> subversion and gets its product through FDA inspection successfully.
> Feedback appreciated!
>
> Best Regards
> --
> Eric Keller
>
> ------------------------------------------------------
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> Id=2376828
>
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> ----- End forwarded message -----
Received on 2009-07-30 17:39:35 CEST