Do You Have the 21 CFR Certification?

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1

This topic was automatically generated from Slack. You can find the original thread here.

Have you guys got a certification called 21 CFR?

2

Not that one specifically, but we have SOC 2 and HIIPA compliancy, does that help?

3

could you link me to information on that? I’m seeing multiple distinct certifications from a quick Google search so I want to make sure I’m looking at the right one.

Would love to know more about the fundamental need — is this something you require of all vendors?

4

I’m asking on behalf of a client that I’m consulting with. I don’t have any more information other than “21 CFR” in terms of the compliance requirement.

They are FDA regulated I believe, so it will be the certification / regulation relating to that?

5

They seemed excited about HIPPA compliance as well…

6

Glad to hear re: HIPAA. I see that FDA guidance and it’s not clear to me how tech companies like us would comply with that directly. If you hear more detail from them / if it becomes a blocker please let me know