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 …
