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 …