BioTrack
Proactive bioburden monitoring & investigation aid
Internal enterprise application — built at Takeda Pharmaceutical
The problem
A single bioburden deviation could take hours to assemble: pulling and reconciling DeltaV, MODA and Labware by hand before any analysis could start — time that ate into the 30-day window reserved for physical inspection, CAPA design and QA review.
Architecture
- DeltaV
- MODA
- Labware
- Alert rates
- Cycle-time corr.
- Organism freq.
- Risk scores
- 6 Plotly types
- Heatmaps · risk matrix
- Trackwise vector search
- Cites real PR numbers only
- LLM narrates R output
- Investigation summary
What it does
BioTrack is a manufacturing investigation aid for bioburden teams, built on the proven TrackLA v2.5.0 architecture. It aggregates DeltaV, MODA and Labware automatically so investigators start from analysis, not data plumbing — preserving the 30-day closure window for the work that actually needs human judgment.
R-first analytics, LLM interpretation
R computes alert rates, cycle-time correlations, organism frequencies and risk scores; the LLM only interprets them. RAG over Trackwise (Databricks Vector Search) pulls relevant past deviations, and an anti-hallucination guard ensures the assistant only cites PR numbers that actually exist in the loaded data.
- Auto-generates 6 Plotly chart types per analysis — equipment heatmaps, scatter plots, trend lines, risk matrices
- Modular design: analytics_orchestrator, visualization_engine, deviation_context, bioburden_rag, bioburden_analytics, equipment_cycle_analytics, file_processor, user_guide