Nymi Offers Answers and a Solution for FDA e-Signature Requirements

“…Nymi Band is a wristband device designed to continuously asses the wearer’s cardiac biometric signals, allowing for entirely passive authentication.”

Nymi is taking the unusual step of lauding government regulations in a new series of blog posts about FDA Title 21 CFR Part 11.

What is FDA Title 21 CFR Part 11? It’s the FDA’s regulation concerning “Electronic records and electronics signatures”. And as Nymi explains in its detailed overview, the regulation caused some major headaches after its official implementation in 1997. That’s because it was designed to start setting some standards for electronic records keeping while also maintaining ‘Good Manufacturing Practices’ in the pharmaceutical industry: Its drafters sought a certain amount of flexibility, but that also meant a certain amount of vagueness that led to confusion for industry players.

While that might sound like a bit of a fiasco, as Nymi points out, before this regulation came along “pharmaceutical manufacturing companies had no standards for ERES and this led to a fractured patchwork of systems across both the manufacturer and industry as a whole.” That led to inefficiencies, and inefficiencies led to increased costs. Seeking compliance with CFR Part 11 has helped companies to streamline many processes, Nymi argues.

Of course, that process is still ongoing – and Nymi is one of the firms offering new technological solutions that can help. Its Nymi Band is a wristband device designed to continuously asses the wearer’s cardiac biometric signals, allowing for entirely passive authentication. It’s also equipped with NFC technology, meaning a user can authenticate just by waving it near a reader device – and that means it offers a unique means of e-signing for medical professionals that is fast and unobtrusive.

It’s a pitch the company made at last year’s Pharma MES & Process Minds conference in Berlin, with these new blog posts offering another indication of Nymi’s intensifying focus on the pharmaceutical industry. The posts may also serve as a useful resource for industry professionals seeking to come to grips with FDA Title 21 CFR Part 11, which is, of course, no simple matter.

Source: Nymi Blog