21 CFR Part 11
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06-02-2016 12:02 PM
21 CFR Part 11 Compliance: Has anyone built and deployed workflows to manage change in ServiceNow that obey 21 CFR Part 11 with full audit trail capabilities and compliant bound electronic signatures?
Also, has anyone performed 21 CFR Part 11 validation testing on the platform?
Thanks!
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06-20-2016 12:36 PM
Yes, Jeff, I have both. Do you have specific questions? Also, please see my blog "FDA Guidance on Data Integrity and Compliance" I just posted today; it has some references to what you may be looking for.
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06-20-2016 01:02 PM
I will browse your recommended link; thanks!
Historically, GxP-regulated companies tend toward something like a Sparta Systems' or Pligrim product for the tracking of change controls that require ERES.
My concern would be if a 21 CFR Part 11 issue would be found with the software, would ServiceNow treat it as a "critical issue for a regulated system" as opposed to a "critical issue for an IT Help Desk system".
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06-20-2016 03:23 PM
Hi Jeff - yes, I'm aware of other specialized products in the GxP space. As to how ServiceNow Inc. would treat a "critical issue," they'll be in the best position to answer that. I have worked with multiple implementations of ServiceNow in GxP environments and am not aware of any "critical" issues related to 21 CFR Part 11 compliance.
