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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.
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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