FDA 21 CFR part 11

[Jeff]

Another set of regulations we probably have to make sure we're observing:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11

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

[Mike D]

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 electronic signature

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