In regulated manufacturing, compliance is often treated as a checklist. A set of SOPs to follow. A training module to complete. A review step at the end of a batch. But in GMP environments – especially in cell therapy and other patient-specific manufacturing models – that approach is increasingly fragile. When compliance depends on perfect human behavior across dozens of handoffs, systems, and time-critical decisions, gaps inevitably emerge. Over the years, our team has observed a clear shift across the life sciences industry: leading organizations are moving from behavior-driven compliance to design-driven compliance. And Manufacturing Execution Systems (MES), when architected …