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FDA 21 CFR part 11
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Jeff  
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 More options Nov 30 2011, 9:57 am
From: Jeff <free...@gmail.com>
Date: Wed, 30 Nov 2011 09:57:41 -0500
Local: Wed, Nov 30 2011 9:57 am
Subject: FDA 21 CFR part 11
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Another set of regulations we probably have to make sure we're observing:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm...

--
Thanks,
Jeff
(j...@freemedsoftware.org)
FreeMED Software Foundation, Inc
http://freemedsoftware.org/


 
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Mike D  
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 More options Nov 30 2011, 10:51 am
From: Mike D <mduk...@gmail.com>
Date: Wed, 30 Nov 2011 10:51:47 -0500
Local: Wed, Nov 30 2011 10:51 am
Subject: Re: [freemed-development] FDA 21 CFR part 11
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This is probably a good idea in general, but may only be REQUIRED if the
particular FreeMED based system is used for drug developing, manufacturing,
dispensing, and/or labeling (FDA regulated process).

If this is the case then this particular installation needs to be validated
(both hardware and software), change managment procedures needs to be
established and executed, and records needs to be maintained for as long as
the system exists and some time after that.

I don't think EHR or billing side of the business falls under FDA
 regulation.

But again, Part 11 provides a good guide on how goverment looks at
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