Workflow Orchestration: Why Executing Steps in the Right Sequence Matters for GMP Compliance
In cell therapy manufacturing, progress isn’t just about moving faster. It’s about moving in the right order. Every therapy follows a tightly defined path. Collection must happen before processing. Processing must complete before quality review. Release can’t occur until every prerequisite is documented. These dependencies aren’t preferences – they’re written into Standard Operating Procedures (SOPs), validated under GMP, and reviewed during FDA audits. Yet many organizations still rely on paper records and manual coordination to enforce that sequence. And that’s where risk quietly enters the process. The challenge: when humans enforce workflows Cell and gene therapy manufacturing involves dozens of …
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 …
How to Digitize Your SOPs Without Disrupting FDA-Validated Processes
In the fast-evolving world of cell and gene therapy, operational efficiency is more than a business goal, it’s a patient safety imperative. Yet, for many CDMOs, CMOs, and biotech companies, the idea of digitizing Standard Operating Procedures (SOPs) triggers a common concern: “What if we disrupt what’s already FDA-validated?” The Challenge Manual SOP management remains the norm in many facilities. Paper binders, siloed spreadsheets, and inconsistent updates can create delays, increase the risk of errors, and complicate audits. While digitization promises efficiency and enhanced traceability, the fear of invalidating FDA approvals often slows progress. Consider this: an operator spends 20–30 …
Why Modular Software Architecture Is Becoming Essential for Cell Therapy Operations
The cell and gene therapy industry operates under a unique set of pressures. Every organization has distinct workflows, different regulatory requirements across regions, and specific operational processes that have been validated over years. Yet many software solutions on the market today force companies into a difficult choice: adopt a rigid, one-size-fits-all platform, or piece together multiple disconnected systems that create data silos and compliance gaps. Neither option serves the patient-centric mission that drives this industry forward. The Challenge: Complexity Without Flexibility GMP manufacturing environments are inherently complex. A CDMO managing multiple client programs needs different capabilities than a biotech running …
