RE: Revision control

[M -dot- Vina-Baltsas -at- mindray -dot- com]

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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From:
"Combs, Richard" <richard -dot- combs -at- Polycom -dot- com>
To:
Gene Kim-Eng <techwr -at- genek -dot- com>, "M -dot- Vina-Baltsas -at- mindray -dot- com" 
<M -dot- Vina-Baltsas -at- mindray -dot- com>
Cc:
"techwr-l -at- lists -dot- techwr-l -dot- com" <techwr-l -at- lists -dot- techwr-l -dot- com>
Date:
12/07/2011 11:55 AM
Subject:
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
303-223-5111
------
rgcombs AT gmailDOTcom
303-903-6372
------









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