What will it take for pharmaceutical shop floors to make information easily available to the specific people in the operation who need it at every moment, without paper or switching between different applications? Stormbit, a new spinoff of Systec & Solutions Group, would say the last mile is paperless labeling and real-time visualization tailored for moving critical GxP data effectively, without replacing existing systems. Its VEYA platform combines hardware, software, and years of industry experience to integrate into existing environments.
Pharma 4.0 Benefits
Many companies are embracing digitalization and Pharma 4.0, and adopting MES, LIMS, and maintenance (EAM), and other enterprise platforms in their operations. Yet many still have some communication processes on paper, so the challenges remain. These include regulatory pressure to go digital; operators often stuck without visibility to the information they need, and paper still causing errors and inefficiencies. Systec & Solutions knows this well, with their HMIs on wheels widely used in pharma cleanrooms and shop floors. They initially developed VEYA to address those challenges, and just this year, spun out Stormbit as an independent company.
Software and hardware in pharmaceutical production must be qualified as part of the validation process that a company conducts. Labels are a critical part of pharmaceutical manufacturing for equipment and materials, and over 10% of cited regulatory violations concern labeling. Rooms with compression or weighing booths also need signs indicating, e.g., what is being made, the batch number, and critical parameters.
Yet, printing paper labels or signs causes contamination – especially in cleanrooms. So printers are elsewhere, protected by airlocks, walls, or floors, and labels are often encased in plastic and wiped down upon entry. All of this leaves room for delays and errors. VEYA intends to end these awkward workarounds.
VEYA Footprint
VEYA delivers multiple paperless “last-mile communication” functions and use cases with a special combination of hardware and software. These include real-time information on digital signage and digital dashboards showing process status. They also include labels to identify and show current status for equipment, equipment calibration schedules and status, containers in motion, and warehouse assets. It can also display the current version of SOPs and work instructions.
It comes complete with connectors to pull from a wide array of data sources, plus LCD or e-paper clients for the displays and labels. The dashboards and display labels are on wireless IP65-rated cleanroom displays. These displays are exclusive to Stormbit and are patent pending. The VEYA platform provides data management to ensure that the correct real-time information appears.
Experience Expedites Startup
Stormbit spun out of Systec & Solutions earlier this year and already has a slide listing half a dozen well-known pharmaceutical companies as clients. They expect to have 10 customers up and running in validated production use by the end of this year. One element of the quick start is that the VEYA hardware/software solutions are offered on a subscription model.
Another factor speeding adoption is an established network and trust in the industry. Systec & Solutions has focused on pharmaceutical manufacturing since its founding in 2013. Plus, the two managing directors, Hermann Schäfer and Jan-Henrik Dieckert, have broad and deep contact networks as long-time pharmaceutical manufacturing software professionals.
Our Take
There’s a clear need for truly paperless operations in the pharmaceutical industry, particularly in cleanrooms. Stormbit’s combination of proprietary hardware and software can bridge the final mile to eliminate paper and printer challenges and begin delivering more information where and when it’s needed. The fact that this came from customer co-development speaks well, and the fact that more customers are already on board just a few months after Stormbit hit the market reinforces that. We expect to see pharmaceutical companies add VEYA to MES, LIMS, EAM, and other manufacturing IT implementations across their cleanrooms and shop floors over time.
Thank You
Thank you to Jan-Henrik Dieckert for introducing Rick Franzosa and me to Stormbit and VEYA, your vision, and your early progress with leading pharmaceutical companies. We look forward to future conversations and following Stormbit’s progress in the market.