RE: [FDA] approval

Most definitely. A company without SOPs will never pass any audits and will never be allowed to ship medical devices.
A majority of our dings have been related to SOP processes, either written with a problem or some paperwork didn't follow the process correctly.
Luckily I don't get hauled in to internal audits, but I do have to set up our use of subversion to match our process, part of which I've help write.
It comes down to "doing what you say and say what you are doing".
Regulatory has a lot of fun here :-)
MB
 --
You design it, I'll build it
e-mail: michael.l.brown_at_philips.com
desk: 608-288-6969
cell: 608-206-6843

-----Original Message-----
From: Pat Farrell [mailto:pfarrell_at_pfarrell.com]
Sent: Thursday, July 30, 2009 9:39 AM
To: users_at_subversion.tigris.org
Cc: users_at_subversion.tigris.org
Subject: Re: [FDA] approval

Brown, Michael wrote:
> 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.

Right, they do inspect and audit that you have SOP and use them.

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

So does my company.

--
Pat Farrell
http://www.pfarrell.com/
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