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.

When used in properly designed and validated architectures, groov EPIC and groov RIO provide secure, time-stamped industrial data and protected communications between field devices and higher-level systems. Secure data and communications help support the authentication, audit, and data-integrity controls required in regulated applications.

We’ve published a short technical overview that explains:

– What 21 CFR Part 11 requires
– How industrial hardware fits into compliant system designs
– How groov products are commonly used in these architectures

If you’re involved in regulated manufacturing systems, it’s a useful reference.

You can download your own copy of the official Opto 22 21 CFR Part 11 documentation from the Opto 22 website.

More questions? Talk to an Opto 22 Engineer today. We're ready to help!