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Mindray is apparently a 4,000-employee medical device manufacturer with
sales all over the world, including the U.S. You certainly have an RAQA
department with people who are well versed in 21CFR820 compliance. I'm a
little surprised that they haven't trained you in it as well, but that's
another thread.
In any case, check with them about your Device Master Records (DMRs) The
DMRs should reference the manuals according to their release history, as
well as other documents that can be cross-referenced to consistently
identify the version of the software. Not the most efficient method
(others have been suggested in this thread), but it's reliable and can
be implemented immediately without releasing new manuals.
Thanks,
Dan Goldstein
Quality Assurance Manager
301-871-1917 (O) | 301-503-2397 (C)
dgoldstein -at- riveraintech -dot- com | www.riveraintech.com
-----Original Message-----
From: M.Vina-Baltsas
Sent: Wednesday, December 07, 2011 11:52 AM
To: Gene Kim-Eng
Cc: techwr-l -at- lists -dot- techwr-l -dot- com
Subject: Re: Revision control
I don't know anything about 21CFR820 compliance (other than what the
internet has) but will mention this as a possible issue at my meeting
this afternoon.
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