Hi there, On Wednesday, November 30, 2011 at 8:00 AM, Hamish Fraser wrote:
> I would also note that we have customized OpenMRS to be compliant with Part > 11 for one research study but are interested as Evan says in more general > "out of the box" capabilities in that area. > > It has been a long time since I've worked in this area, but wouldn't Part 11 "compliance" (a bit of a misnomer?) on our part as a vendor require us to go through the FDA's Computer System Validation (CSV) process? If so, we've got quite a lot of work ahead in defining functional/non-functional requirements and providing traceability from system functions to those requirements, not to mention testing and documentation for each release. Michael _________________________________________ To unsubscribe from OpenMRS Developers' mailing list, send an e-mail to [email protected] with "SIGNOFF openmrs-devel-l" in the body (not the subject) of your e-mail. [mailto:[email protected]?body=SIGNOFF%20openmrs-devel-l]
