Fabian Fitzer

IT/OT Integration in the Pharmaceutical Industry: Scaling in a GMP-Compliant Way

How can digitalization in the pharmaceutical industry succeed under GMP conditions? In this episode, Vetter Pharma and soffico demonstrate how IT/OT integration can be implemented sustainably even in highly regulated environments. The starting point: paper-based GMP documentation, high manual effort, heterogeneous machine and laboratory systems, and strict requirements for data integrity, validation, and auditability. At the same time, a scalable data foundation for future use cases was missing. The approach: a central data integration architecture based on the Orchestra platform from soffico. Instead of point-to-point connections, Vetter relies on a standardized, three-layer architecture covering the OT level, aggregation layer, and IT level. QA, validation, and operations were integrated from the very beginning. Automation using Kubernetes and CI/CD enables scalability while maintaining compliance. The result: fewer manual checks through “review by exception,” consistent data for MES, LIMS, and analytics applications, and a robust foundation for data-driven optimization — all the way to AI-based use cases. The episode is aimed at managers in regulated industries who want to implement IT/OT integration strategically and for the long term.