Software upgrades, data integrity, and data security – oh my!

Daryl Krushinsky, Senior Director Operations OUIT Solutions, Eurofins BioPharma Product Testing

The quote, “Lions, and tigers, and bears, oh my,” was made famous by Dorothy, the Tin Man, and the Scarecrow while walking through a dark forest in The Wizard of Oz. It was used to express fear and anxiety about unknown dangers and is often used now to refer to daunting (or scary) tasks that we encounter. These feelings resonate as headlines remind us of evolving IT security threats and constant IT breaches across the globe. We know that we must continuously improve and upgrade laboratory data systems to stay ahead of these new data integrity and data security threats, however, we must also do so in a controlled manner within the heavily regulated biopharmaceutical environment.

Hackers utilize many tools to gain entry into company networks. Falling victim to a simple phishing scam can provide them with just enough access to gain necessary credentials to overtake a network and/or plant malware or ransomware. The Eurofins approach to mitigate this risk is two-fold. First, we require on-going and in-depth IT security training for every employee to increase their awareness and vigilance. Second, technological controls minimize risk by detecting unusual activity and by limiting access across the network. Training programs are relatively easy to implement, but changing behavior is a bit more difficult. Harder still, is ensuring that technology remains current in a regulated industry.

The basis for implementing technological control for detection and minimizing access risk is to ensure that all networked laboratory system computers and servers remain on currently supported Windows Operating System (OS). This ensures that they remain supported and continue to get upgraded security patch releases as new threats emerge. Upgrading the OS may often require an upgrade to the existing instrument software application to ensure ongoing compatibility and proper functionality. This can then also necessitate upgrade or replacement of the instrument itself – oh my!

Rather than following the Yellow Brick Road, the team at Eurofins navigates these changes with a robust and well-established change management program to make the journey less daunting. There is no shortage of enhancement and implementation projects to improve data integrity and data security efforts. A few select highlights are included below:

• Softmax^® Pro Enterprise software is currently being tested and validated for implementation in late 2025 and will manage the fleet of plate readers at Eurofins. This version will centralize system administration efforts to provide greater control over previous stand-alone software versions. Also, the enterprise version utilizes a database to enhance data security and integrity by eliminating the prior flat-file structure. Additionally, this version incorporates the use of electronic signatures to improve integrity of data analysis and review workflows.
• LabSolutions™ is an additional enterprise level software being implemented to manage a new series of UV/Vis detector. Once fully validated, LabSolutions will permit the phase-out of two related software systems and associated detector hardware that are outdated and are not compatible with current computer and server OS requirements. As noted previously, current and supported Operating Systems are required to ensure continued security patching to detect new threats.
• Kneat^® software has been in use within Eurofins for several years. The system provides a paperless process with electronic signature capability. It automates laboratory instrument validation with a “poka-yoke” process by providing prompts for required inputs to improve compliance. Kneat has recently undergone change control to modernize the underlying structure, which permits continued system improvements and compatibility with future OS upgrades and patching.

Eurofins continually mitigates the numerous challenges with maintaining laboratory systems that provide accurate results AND remain secure and compliant in the face of new threats. There is no need to worry about the “dark forest” of computerized system upgrades at this trusted contract laboratory. Whether it’s adding the newest technology or updating current systems, Eurofins is committed to supporting our clients with a proactive approach to laboratory system data integrity and data security.

For more information visit: www.Eurofins.com/BPT or: Contact Us to submit an inquiry.