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.
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.
Nymi’s solutions reside under subpart C of the title, which focuses on electronic signatures. The general requirements relating to electronic signatures are:
“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.
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.
As such, we wanted to share the schedule of where we'll be this year.
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.
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.
As manufacturing goes digital, security and thus authentication take center stage. Productivity is still the desired happy ending. While authentication can be the hero, in many cases, it is the villain. Why? Because the models many companies use are broken or outdated.
Data integrity matters more than ever, and may seem more challenging than ever. Welcome to Industry 4.0, based on Cyber-Physical Systems (CPS) and data everywhere. Fortunately there’s a CPS that can address this situation.
September 28th and 29th saw Nymi’s attendance at the Pharma MES & Process Minds conference in Berlin. The show is a leading knowledge exchange platform for pharma manufacturing around the globe, bringing together key stakeholders who play an active role within pharma and life science manufacturing.