Is groov EPIC CFR Part 11 compliant?

groov EPIC
1

Especially curious about support for Audit Trail and Electronic Signatures

2

For 21 CFR Part 11 compliant on the groov EPIC, we rely on the onboard Ignition software package for this:
21 CFR Part 11 Ignition Compliance Documentation
Ignition 21 CFR Part 11 White paper

3

Thanks @greichert. My understanding is that both Ignition and Ignition Edge are optional modules in groov EPIC. If that is the case, is it fair to say groov EPIC is not CFR Part 11 compliant when Ignition is not used?

4

The groov EPIC PR1/2 comes pre installed with Ignition. If the project requires that the controller be 21 CFR part 11 compliant , then you would use Ignition and its modules.