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Pharma Forum 2026 – Unified Namespace (UNS) in the GMP Environment

From vision to reality? At the Pharma Forum 2025, we discussed the potential of the Unified Namespace. In 2026, we’ll be discussing its implementation in a regulated environment. We didn’t just discuss UNS in theoretical terms; we tested it in a real-world project setting.

As part of a proof of concept, the following components were developed and validated:

Redundant OPC UA Servers (Open PCS7)
HiveMQ Edge Gateways
Redundant MQTT Broker Cluster
Integration with AVEVA PI
Implementation of failover, buffer, and recovery scenarios

The goal was to create a robust, GMP-compliant architecture. This is because existing production environments in the pharmaceutical industry are stable—but have evolved over time. Although the PCS7 system environments run reliably and a connection to the PI Historian has been established, additional interfaces have been added over the years. However, the architecture increasingly resembles a network of point-to-point connections.

New requirements are making the situation even more difficult:

Stricter transparency requirements
More data users (analytics, data science, MES, reporting)
The need for scalable architectures
Strategic initiatives such as smart manufacturing

The key question:

How can production data be made future-proof without compromising compliance with the ?

We worked with our client to address precisely this question. As OT experts, we didn’t just focus on the technical integration; we also examined data integrity, redundancy strategies, and buffer and recovery scenarios in particular, and incorporated them into a robust GMP architecture.

In practice, it becomes clear where the real added value lies: systems no longer need to be directly connected to one another, but instead communicate via a central, structured data platform. New applications can be integrated more quickly, and additional data consumers can be added without having to rewire the existing architecture. Production data is available for evaluation and analysis in near real time, while the overall architecture becomes more flexible and easier to scale in the long term.

But this is precisely where false expectations often arise. A unified namespace is not a product that you simply install and that then automatically brings order. Without a clear structure, binding naming conventions, defined governance, and coordinated responsibilities between IT and operations, no added value is created—instead, a new, difficult-to-manage data environment emerges. The technical implementation is feasible. What matters most is architectural discipline.

Conclusion: The unified namespace works. But it’s not as simple as it’s portrayed in many presentations.
Picture of Sascha Zeller, Team Leader OT Solutions at ControlTech Engineering AG.

How can a unified namespace be implemented in compliance with GMP?

Book a non-binding meeting with Sascha Zeller, Head of Data Management.

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If you’d like to learn how we’ve implemented this approach in practice and what insights can be drawn from it for regulated production environments, please attend our presentation at the Pharma Forum.