Re: Revision control

Subject: Re: Revision control
From: Gene Kim-Eng <techwr -at- genek -dot- com>
To: Dan Goldstein <DGoldstein -at- riveraintech -dot- com>
Date: Wed, 7 Dec 2011 10:32:24 -0800

>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.
>
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

Create and publish documentation through multiple channels with Doc-To-Help.
Choose your authoring formats and get any output you may need. Try
Doc-To-Help, now with MS SharePoint integration, free for 30-days.
http://www.doctohelp.com

---
You are currently subscribed to TECHWR-L as archive -at- web -dot- techwr-l -dot- com -dot-

To unsubscribe send a blank email to
techwr-l-leave -at- lists -dot- techwr-l -dot- com
or visit http://lists.techwr-l.com/mailman/options/techwr-l/archive%40web.techwr-l.com


To subscribe, send a blank email to techwr-l-join -at- lists -dot- techwr-l -dot- com

Send administrative questions to admin -at- techwr-l -dot- com -dot- Visit
http://www.techwhirl.com/email-discussion-groups/ for more resources and info.

Looking for articles on Technical Communications? Head over to our online magazine at http://techwhirl.com


Follow-Ups:

References:
Revision control: From: M . Vina-Baltsas
Re: Revision control: From: Gene Kim-Eng
Re: Revision control: From: M . Vina-Baltsas
RE: Revision control: From: Dan Goldstein

Previous by Author: Re: need suggestions on handling a boss
Next by Author: Re: need suggestions on handling a bos
Previous by Thread: RE: Revision control
Next by Thread: RE: Revision control


What this post helpful? Share it with friends and colleagues:

Sponsored Ads


Sponsored Ads