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Has Anyone Qualified RQM as Compliant to 21 CFR Part 11


Paul Spalitta (8142836) | asked Oct 12 '15, 9:29 p.m.
Is anyone using RQM in compliance to 21 CFR Part 11? If yes which version of RQM are you using? And do you feel that creative solutions were required to show RQM as compliant to the Part 11 regulations?

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Paul Slauenwhite (8.3k12) | answered Nov 23 '15, 7:41 a.m.
FORUM MODERATOR / JAZZ DEVELOPER
Although RQM can assist a test team in achiving compliance with 21 CFR Part 11 in their processes, the product itself is not 21 CFR Part 11 compliant.

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Paul Spalitta commented Dec 04 '15, 10:40 a.m.
Hi Paul,

Yes, agreed, hence the phrasing of my question. Part 11 compliance must be established and validated by anyone operating under FDA regulations. A system like RQM just provides some of the tools a company needs to establish compliance.

I raised this question because sometimes it seems we are doing a bit of trail-blazing upgrading to more recent versions of RQM and using features targeted at the regulated community. And we are only just now upgrading to v5.0.2! BTW: RQM 5.0.2 is looking good.

Best regards,

Paul Spalitta 

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