RegenLedger

RegenLedger is a web app (with optional mobile companion) for regenerative medicine labs and early-stage cell therapy biotechs to manage chain-of-identity and chain-of-custody across patient samples, manufacturing runs, QC results, and shipment events. It replaces brittle spreadsheets and email threads with a structured, audit-ready event log: who handled what, when, under which SOP, and which lot it became. The MVP focuses on operational traceability rather than trying to be a full LIMS/MES (which is expensive and slow to implement). It supports barcode/QR scanning, role-based approvals, deviation logging, and exportable audit packages for internal QA and partner due diligence. An AI layer can draft deviation summaries, flag missing steps, and suggest likely root-cause categories from free-text notes, but it does not “diagnose” or make clinical claims. This is unglamorous software, but it’s exactly what teams need to avoid costly mix-ups and failed audits.