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RQM and FDA compliance


Mikael Öqvist (633) | asked May 05 '10, 8:36 a.m.
Is RQM FDA compliance. If so, wich level?

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Patrick Van Zandt (1.2k1) | answered May 05 '10, 2:20 p.m.
JAZZ DEVELOPER
Is RQM FDA compliance. If so, wich level?

FDA compliance? Can you elaborate on what that is?

If it is the same/similar to Federal Desktop Core Configuration (FDCC) compliance, see the FDCC Compliance section of the system requirements article in the product documentation.

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Mikael Öqvist (633) | answered May 06 '10, 6:20 a.m.
Hi! No Its the Food And Drug Admin. Check this link:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

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