Case Study: Shire achieves real-time validated process control and data-analysis efficiencies with Statistica

Shire - Customer Case Study

Shire’s Rare Diseases Business Unit, a specialty biopharmaceutical division, faced fragmented, manual data workflows across LIMS, Excel and other tools that made statistical process control and real-time process monitoring slow, error-prone and hard to validate. The team needed an off‑the‑shelf, validatable analytics solution to consolidate data, ensure accuracy and support manufacturing operations across multiple sites.

Shire implemented Statistica across development, validation and production environments, building a validated LIMS connection and using Enterprise Workspaces to create configurable analytic flows and web-published reports without programming or IT support. The single validated entry point and automated reporting cut data-entry errors, sped access to real‑time insights, improved cross‑site comparisons and root-cause analysis, reduced operational risk and costs, and enabled proactive interventions — with Phase II extending the solution to external manufacturing and stability data.

Shire

Gloria Gadea-Lopez

Director of Manufacturing Systems