Data-Driven Pharma — Why Technology Alone Doesn't Fix the Shop Floor

Florian Seidl (cts Group) and Florian Werner (Xenium) on data silos, change management, and building trust across IT, OT, and the organization

00:00 — Intro & Who We Are Florian Seidl (cts Group, Industrial Informatics) and Florian Werner (Xenium, IT & Management Consultancy) introduce themselves and their respective focus areas.

02:00 — The Reality on the Pharma Shop Floor Package-unit driven organizations, fragmented vendor landscapes, multiple PLCs with different protocols, and why data strategy is often an afterthought.

06:00 — Unified Namespace and ISA-95 Why operators, process engineers, and data analysts need to speak the same language — and why pharma often lacks the tag naming conventions that other industries have established.

12:00 — Project Approach: Strategy to Operations The joint methodology from scoping and project planning through delivery, rollout, and handover. Why the "technology, processes, humans" triangle determines success or failure.

18:00 — Change Management: The Make-or-Break Phase A real example of a system implemented two years earlier that nobody used. Why even a perfectly working IT system fails without organizational adoption. The "background is gray, not green" anecdote.

26:00 — Trust as the Foundation Building trust on every level — management, IT, OT, and the shop floor. The "front runner site" concept for rollouts. Why trust can't be built overnight but compounds once established.

33:00 — IT vs. OT: Two Different Worlds Regular update cycles vs. 10-year system lifetimes. Validated environments vs. agile deployment. How the industrial data fabric bridges the gap between IT flexibility and OT stability.

42:00 — Concrete Use Case: MES-to-OT Message Brokering Standardized message templates between MES and shop floor systems (Simatic Batch, PLCs). How reusable communication classes reduce implementation effort from site to site.

50:00 — Data Harmonization Across Sites 50+ devices, same measurements, completely different naming — and why data harmonization on a higher layer is the real challenge, not the data layer itself.

57:00 — From Use Case to Platform Why the industrial data fabric should not be scoped for a single use case but as an enabler for future data-driven initiatives. The AI readiness argument: harmonized data in one place is a prerequisite, not a nice-to-have.

1:03:00 — Regulatory Reality: GxP, Validation, and Compliance DQ and Production system environments, change management in validated settings, and how an established platform makes extending into regulated use cases faster.

1:11:00 — Data Lakes vs. Data Swamps Why "just send everything to the cloud" creates data swamps. The shift from collecting all data to identifying which data points actually matter — and why that requires cross-functional teams, not just IT.

1:20:00 — Scaling and the Evolution Phase Once the platform is in place, new use cases become dramatically faster. Why you should plan for evolution, not just go-live — and why trusting internal people to take ownership is what makes a transformation stick.

1:27:00 — Outlook: Pharma Manufacturing Europe Both Florians look ahead to joint conversations at the conference in Berlin — understanding where pharma companies are on their data journey and showing what's already possible.

Moderation: Florian Seidl

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