Nymi Blog

Digitalizing Pharma Manufacturing: Next Steps include MES and Nymi

Posted by Alison Lee on Oct 15, 2018 12:07:35 PM

A fully digital and smart workplace offers many benefits: lower costs, improved quality, and higher productivity. Nearly everyone agrees about that. Yet in pharmaceutical manufacturing, the pace of change has been slow. Most companies still use at least some paper-based systems to guide and document processes. These entrenched and validated systems limit productivity and agility.

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Topics: Conferences, News

More Ways to Authenticate with Nymi Confidently

Posted by Geoff Oliver on Aug 21, 2018 8:24:50 PM

Want more ways to ensure compliance with user data authentication? Or more confidence in the Nymi approach? If so, our news is good news. So far, 2018 has been an incredibly exciting year for Nymi, from winning awards and entering new strategic partnerships to launching our latest authentication solution, Nymi Enterprise Edition™.  

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Topics: News

Why FDA Title 21 CFR Part 11 matters more than ever - Part 1

Posted by Geoff Oliver on Apr 5, 2018 4:09:35 PM

This three-part blog series revisits an age-old topic through the lens of the latest technology. Starting with a brief introduction to the history of Title 21 CFR Part 11, we’ll take you through the industry changes that enable better data reliability and significant performance improvements over the traditional use of electronic signatures.

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Why FDA Title 21 CFR Part 11 matters more than ever - Part 2

Posted by Geoff Oliver on Apr 5, 2018 4:09:17 PM

Title 21 CFR Part 11 has added much-needed clarity to how companies need to approach Electronic Record Electronic Signature (ERES)  (to catch up on the history of the rule, click here.) Knowing what the rule entails is essential, but even more important is understanding how Part 11 impacts the day-to-day operation of a manufacturer.

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Why FDA Title 21 CFR Part 11 matters more than ever - Part 3

Posted by Geoff Oliver on Apr 5, 2018 4:09:06 PM

To complete our series on Title 21 CFR Part 11, let’s look at how manufacturers can use Nymi authentication solutions to help ensure compliance but also improve data integrity and user productivity.

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Topics: News

Non-repudiation is non-negotiable in regulated manufacturing

Posted by Geoff Oliver on Jan 30, 2018 5:23:38 PM

“It wasn’t me.” This phrase is something we’ve all said or heard at some point in our life, whether in response to glass breaking or a teacher’s stern glance at the corner of the classroom. In everyday life, passing the buck may not carry significant repercussions; in the tightly regulated pharmaceutical manufacturing industry, however, the stakes are much higher. It is imperative that a company uncovers where an error occurred in the manufacturing process since the burden of proof lies with the company. Failing to do so can have severe consequences, both in lost revenue and regulatory fines. This is where non-repudiation plays a crucial role.

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Topics: Insider

Nymi 2018 Trade Show Schedule

Posted by Geoff Oliver on Jan 24, 2018 5:00:24 PM

Welcome to 2018! There are a lot of exciting things coming down the pike this year for Nymi, not the least of which is our expanded trade show presence in the IIoT and pharmaceutical manufacturing spaces. Being able to get face-to-face with current and future partners and having frank discussions as to the problems they're facing in the authentication space is extremely beneficial and rewarding.

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Topics: News

Serialization is coming: Think beyond the box

Posted by Geoff Oliver on Dec 14, 2017 9:58:00 AM

Are you overlooking something in preparing for the Drug Supply Chain Security Act (DSCSA)? DSCSA will be mandatory in just under a year, and similar to many companies, you may primarily be focused on what to put on pallets, cartons, and packages; However, there are broader concerns that you overlook at your own peril – and that of the patients: data integrity.

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Biomanufacturing World Summit 2017

Posted by Geoff Oliver on Nov 28, 2017 10:44:00 AM

On November 13th and 14th, the Nymi team was onsite at the Biomanufacturing World Summit in San Diego. Similar to the show we attended in Berlin (see that post here), this latest show was a mixture of keynote speaker sessions and having one-on-one conversations with thought leaders in pharmaceutical manufacturing. This format meant that we were able to both demonstrate the Nymi solution, but also gain insight as to where the industry is heading, and what it will take to get there.

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