First, The International Conference on Harmonization of Technical 
Requirements for Registration of Pharmaceuticals for Human Use  (ICH) has 
worked hard to harmonize most major regulations the FDA and foreign 
regulating bodies use, although it's not 100% accurate. You may want to 
check there as well. http://www.ich.org/cache/compo/276-254-1.html

Second, If your client knows that people are taking home records against 
company policy, it should be a concern. The FDA audits company policies 
and procedures for adherence to the regulations as well as best practices 
(GxP). They also look at employee training files for company compliance. 
Lack of following either known regs or company polices can bring FDA audit 
findings and/or warning letters.  So, if your client company has a "do not 
bring home" policy, and an auditor finds that employees are breaking that 
policy due to lack of proper training or education, it could spark an 
audit finding. 
 I hope that helps. 

Cheers, 

Melissa 




"Su D. A. Graham" <[log in to unmask]> 
Sent by: Records Management Program <[log in to unmask]>
09/11/2008 10:41 AM
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Records Management Program <[log in to unmask]>


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Subject
FDA Warning Letters






Hello All,

A general question came from a pharmaceutical client in a foreign country. 
 This client is required to follow FDA regulations and was concerned about 
a possible warning letter concerning RM practices of storing data, records 
and especially backup tapes in employees' homes. 

I have searched the FDA Warning Letters website -- 
http://www.fda.gov/foi/warning.htm -- and could not find any warning 
letters pertainent to the above issues.  Does anyone know otherwise?

Thank you.

Su

Su D. A. Graham, CRM, MLS
Graham Information Management Associates
15 Conestoga Road / Black Hawk, CO  80422
Voice:  (303) 642-7802 / Fax:  (303) 642-0115
Email:  [log in to unmask] / Web:  GrahamInfo.com

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