Are you sure a "data center" was actually meant or did he really mean an
archive/records center? FDA has some pretty strict guidelines for a GLP
compliant archive/record center. 

I have no knowledge of the FDA having any regulations for a true data
center. 

-----Original Message-----
From: Records Management Program [mailto:[log in to unmask]] On
Behalf Of Hugh Smith
Sent: Friday, August 11, 2006 12:41 AM
To: [log in to unmask]
Subject: Re: [RM] FDA Requirements for pharmaceutical

For some of our friends who work in the pharmaceutical industry,
I was asked this question by  someone in South America:

> Our client is required to construct new datacenter that complies with 
> the FDA regulations.

Has anyone ever heard of the FDA setting standards for building a Data 
Center?

If there is no real specification, would any of the general FDA records 
keeping requirements impact on building a data center?

Hugh

Hugh Smith
FIRELOCK Fireproof Modular Vaults
[log in to unmask]
(610)  756-4440    Fax (610)  756-4134
WWW.FIRELOCK.COM

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