BatchTrace

BatchTrace is a web app (with optional mobile companion) for biologics teams to track deviations, CAPAs, and batch genealogy in one place—without trying to replace your entire eQMS/MES. It focuses on the messy middle: linking a deviation to specific lots, raw materials, equipment, operators, and downstream impacted batches, then generating a clean “impact map” for QA review. The app ingests key identifiers via CSV/API from LIMS/MES, lets users tag events in real time, and maintains an audit-ready timeline. An AI assistant can draft deviation narratives, suggest likely root-cause categories based on historical patterns, and flag missing data needed for closure, but humans approve everything. The goal is faster investigations, fewer repeat deviations, and less time spent chasing context across systems and spreadsheets.