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Re: Consequences of not Having Operational Documentation in Place

Subject: Re: Consequences of not Having Operational Documentation in Place
From: Kat Nagel <mlists -at- masterworkconsulting -dot- com>
To: "TECHWR-L" <techwr-l -at- lists -dot- raycomm -dot- com>
Date: Thu, 5 Sep 2002 19:08:38 -0400


At 1:50 PM -0700 9/5/02, Steven Brown wrote:

if there's any chance of
working within the pharmaceutical industry or
partnering with a pharmaceutical company, you may be
required to document how you maintain your IT systems.

This is the 21 CFR Part 11 stuff that everyone's
raving about.


There are similar requirements for CMM certification and ISO registration.

Kat Nagel
--
Kat Nagel, MasterWork Consulting Services
"The nice thing about standards is that you have so many
to choose from; furthermore, if you do not like any of them,
you can just wait for next year's model."
Andrew S. Tanenbaum, _Computer Networks_, 3rd ed, 1996


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