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>From what Michelle said in her follow-up, compliance issue may depend on
the auditor. The company has the records and can probably produce them in a
document control audit, but it's not being disseminated within the company
to everyone who could need it. The CFR governs record keeping, but doesn't
address accessibility or usability.
Gene Kim-Eng
On Wed, Dec 7, 2011 at 9:50 AM, Dan Goldstein
<DGoldstein -at- riveraintech -dot- com>wrote:
> 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.
>
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