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groov and 21 CFR Part 11 - what you need to know

Posted by Dan White on Feb 4, 2026 7:31:54 AM

New document outlines how groov products are being used in 21 CFR Part 11 approved applications.

If you work in pharmaceutical or biotech manufacturing, you’ve probably had to think about 21 CFR Part 11, the FDA regulation that governs electronic records and electronic signatures.

Most of the Part 11 requirements live in supervisory systems like SCADA, MES, and historians. But those systems depend on one thing: reliable, traceable data from the equipment layer.

That’s where Opto 22’s groov platforms come in.

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Topics: groov EPIC, groov RIO, groov rio emu, 21 CFR Part 11

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