Case Study: Biopharmaceutical company BioMarin achieves stronger GMP compliance and paperless maintenance with Infor EAM

BioMarin Enhances GMP Compliance and Workflow with Infor EAM

BioMarin, a Novato, California–based biopharmaceutical company focused on enzyme replacement therapies for rare diseases, needed to scale maintenance across 10 buildings and 500,000 sq ft while preserving product quality. Rapid growth exposed gaps in targeted maintenance and reliability-centered maintenance (RCM), GMP compliance, paper-based processes, and fragmented equipment, calibration, and inventory data.

BioMarin implemented Infor EAM with Infor EPAK to create a single source of truth and standardized business processes, adding KPIs, e-signatures, calibration tracking, SDLC/UAT validation, and cloned work-order screens to replace paper forms. The result was stronger cGMP demonstrability, streamlined training (175 EPAK scripts), improved inventory management with less downtime and fewer rush orders, and increased maintenance capacity and compliance.

BioMarin

Jim Kroyer

Principal Engineer, Equipment Reliability