How MES Helps Ensure GMP Compliance in Manufacturing
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 …
5 Signs Your Lab Has Outgrown Spreadsheet-Based Sample Tracking (and What to Do Next)
Spreadsheets have supported life sciences teams for decades. They’re familiar, flexible, and quick to set up. But as labs scale, especially in regulated environments like cell therapy, biobanking, and advanced biologics – what once worked can quietly become a source of risk. Over the years, our team at Pragmatrix has had the opportunity to work alongside CDMOs, CMOs, and biotech organizations navigating this exact transition. A consistent pattern emerges: spreadsheets don’t usually “fail” overnight. They simply stop keeping pace with operational and regulatory realities. Here are five signs your lab may have outgrown spreadsheet-based sample tracking and key considerations for …
