Pharmaceutical Logistics

The client manufactures temperature-sensitive biologics across 22 sites in Europe, the Americas, and Asia-Pacific. Serialization compliance was patched across disconnected systems; cold-chain excursions were detected hours after they occurred; and validation evidence for cross-border shipments required manual reconciliation against four different track-and-trace authorities. Operational shrinkage was visible only in the quarterly close.

We engineered a unified supply-integrity platform around GS1 standards and EPCIS as the canonical event model, integrated to the existing Werum PAS-X MES and Veeva Vault QMS. Cold-chain telemetry was instrumented through MQTT Sparkplug B gateways at every cold-storage and in-transit asset; anomaly detection runs continuously against the event spine; deviations trigger remediation workflows automatically. The full platform was validated under GAMP 5 / 21 CFR Part 11, with electronic signature and change-control engineered into the deployment pipeline itself.

Cold-chain shrinkage variance dropped 40% year-on-year, with the remaining excursions now detected and contained inside operational SLA. Regulator submissions across the four authorities draw from a single evidentiary surface — no more manual reconciliation. The platform now operates as the supply-integrity backbone for every new product introduction.