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
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(610) 756-4440 Fax (610) 756-4134
WWW.FIRELOCK.COM
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