RE: Revision control

Subject: RE: Revision control
From: M -dot- Vina-Baltsas -at- mindray -dot- com
To: "Combs, Richard" <richard -dot- combs -at- Polycom -dot- com>
Date: Wed, 7 Dec 2011 12:02:56 -0500

Let me clarify...

We have a very strict document control process in place internally but
that is transparent to our clients.

We have change control documents that contain revision blocks, as Gene
mentioned, but the client does not see any of that.


Michelle Viña-Baltsas
Senior Technical Writer

800 MacArthur Blvd.
Mahwah, NJ 07430

Tel: 201-995-8350
m -dot- vina-baltsas -at- mindray -dot- com

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"Combs, Richard" <richard -dot- combs -at- Polycom -dot- com>
Gene Kim-Eng <techwr -at- genek -dot- com>, "M -dot- Vina-Baltsas -at- mindray -dot- com"
<M -dot- Vina-Baltsas -at- mindray -dot- com>
"techwr-l -at- lists -dot- techwr-l -dot- com" <techwr-l -at- lists -dot- techwr-l -dot- com>
12/07/2011 11:55 AM
RE: Revision control

Gene Kim-Eng wrote:

> It seems to me that you have a 21CFR820 compliance problem if you can't
> cross-check your document revisions against their associated device
> versions.

Yeah, it's hard for me to believe that a US medical device manufacturer
wouldn't have a tightly controlled process in place for releasing new
versions and their docs. Aside from the thousands of pages of regulations,
there are liability issues...

Richard G. Combs
Senior Technical Writer
Polycom, Inc.
richardDOTcombs AT polycomDOTcom
rgcombs AT gmailDOTcom


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Revision control: From: M . Vina-Baltsas
Re: Revision control: From: Gene Kim-Eng
RE: Revision control: From: Combs, Richard

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