Data integrity is essential in pharmaceutical production. The Japanese Kowa Optronics Co.,Ltd recently launched the biometric Nymi Band – a new product that allows secure authentication in sensitive environments. The zenon platform from Austrian software manufacturer COPA-DATA uses this for controlled access and complete logging.
The pharmaceutical industry is governed by strict regulations, such as the European GMP (Good Manufacturing Practice) and the US FDA 21 CFR Part 11, which stipulate high standards of data quality and traceability: The authentication of user access and electronic signatures plays a key role here. However, procedures such as passwords or chip cards are increasingly being viewed critically: They can be manipulated, lost or used by unauthorized persons.
Biometric identity
This is where the innovative wearable solution comes in: "In a joint project, an interface was developed that makes it possible to integrate the Nymi Band directly into zenon as a biometric authentication device," says Tadataka Une, Director and Country Manager COPA-DATA Japan. "Customers who already use the zenon software platform can also introduce the Nymi Band." The wristband is activated once using a fingerprint. It then continuously checks the wearer's biometric identity – based on their individual heart rhythm – for login processes and electronic signatures. This ensures that only authorized persons have access to production-relevant data and systems: a significant increase in data security compared to conventional methods.
Nymi Band is a smart, future-oriented solution.
Fulfilling regulatory requirements
The integration not only enables authentication without a password or chip card, but also a legally compliant electronic signature with just one hand movement – even if the operating personnel are wearing gloves. It is also possible to log who is accessing which system in real time. Unauthorized persons are automatically blocked. The system therefore meets all FDA requirements and GMP guidelines while reducing the administrative workload for audits.
Password management not applicable
The advantages for pharmaceutical production are obvious: biometric authentication prevents data manipulation and increases traceability. At the same time, it increases efficiency, as time-consuming password management is no longer necessary. System administrators also benefit, as user administration is considerably simplified.
Focus on other sectors
"The combination of zenon with the Nymi Band is considered a pioneering solution for smart factory concepts," says Tadataka. "And not just in the pharmaceutical sector, but also in other highly regulated industries such as automotive, food and energy." The first applications outside the pharmaceutical industry are already demonstrating the broad application potential.
For more information visit Nymi Band.
COPA-DATA is an independent software manufacturer that specializes in digitalization for the manufacturing industry and energy sector. Its zenon® software platform enables users worldwide to automate, manage, monitor, integrate and optimize machines, equipment, buildings and power grids. COPA-DATA combines decades of experience in automation with the potential of digital transformation and a strong drive for sustainability-enabling solutions. In this way, the company supports its customers to achieve their objectives more easily, faster and more efficiently.
The family-owned business was founded by Thomas Punzenberger in 1987 in Salzburg, Austria. In 2024, with more than 450 employees worldwide, it generated revenue of EUR 99 million. A sales network of international distributors and 14 subsidiaries ensures that the software is marketed worldwide. More than 350 certified partner companies further support end users with the efficient implementation of the software, particularly in the key industries of food & beverage, energy & infrastructure, automotive and pharmaceutical.
