RE: [FDA] approval

The FDA doesn't inspect the tools that you use, you do. Your SOP explains how you test the tools that you use and how you qualify them.

We use Subversion for our software and we are FDA control as well.

Because you fully test and qualify the software that you produce, part of the verification of your tools is handled by the fact you test your software. That said, what you are after is that what you put into subversion is what you get out.

So, bottom line, do not overthink it.

MB

 --
You design it, I'll build it
e-mail: michael.l.brown_at_philips.com
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From: Eric Keller [mailto:keller.eric_at_gmail.com]
Sent: Thursday, July 30, 2009 1:50 AM
To: users_at_subversion.tigris.org
Subject: [FDA] approval

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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