Your Electronic Batch Record should be built during production — not assembled after it ends
Connect bioreactors, analytical instruments, LIMS, MES, ELN, and ERP in one place. FlowFuse helps teams automate batch stage coordination, maintain 21 CFR Part 11 data integrity, and carry process logic from development through to commercial GMP production.
The Problem Today
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Scientific instruments operate as isolated systems — process events on one cannot trigger actions on another without manual intervention, consuming scientist and operator time that should be spent on higher-value work.
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Electronic Batch Records are assembled after production by pulling data from MES, LIMS, historian, and paper logs — delaying batch release, introducing data integrity risk, and failing the contemporaneous data standard that FDA and EMA inspectors require.
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Scale-up and technology transfer require rebuilding operational workflows at each stage — development process logic doesn't carry forward without significant rework, extending time to first GMP batch.
What You Get with FlowFuse
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One platform to connect instruments and systems (bioreactors, analysers, LIMS, MES, ELN) via open protocols — without replacing any of them or renegotiating vendor contracts.
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Low-code automation built on Node-RED so scientists and engineers can configure and iterate workflows without vendor dependency or specialist IT.
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Dev/test/prod environments that support GMP computer system validation (CSV) requirements and enable controlled, auditable deployment across scales and sites.
Key Outcomes for Life Sciences Manufacturers
Complete EBR at end of production with process parameters, quality results, and operator confirmations captured continuously as the batch progresses — QA-ready without post-production compilation.
Accelerate batch stage transitions by automating hold/release decisions and downstream equipment scheduling from LIMS results — eliminating manual coordination delays between operations.
Reduce tech transfer and scale-up rework with parameterized workflow templates that carry process logic from development through clinical to commercial GMP — configuration, not rebuild.
Improve deviation response with automatic workflow initiation at point of parameter exceedance — full batch context captured without manual reconstruction, CAPA initiated with full linkage.
Use Cases
Instrument integration and automated batch stage coordination — bioreactor phase completion, LIMS in-process results, and equipment scheduling for the next operation connected automatically; hold/release decisions executed without manual intervention for standard cases; full stage transition record maintained without separate documentation effort.
Continuous Electronic Batch Record assembly — process parameters, equipment status, operator confirmations, and quality results captured at each step as the batch progresses; EBR complete and QA-ready at end of production with discrepancies flagged in real time, not during post-production review.
Deviation and CAPA workflow — parameter exceedance or alarm condition triggers automatic deviation workflow; batch position, process parameters, and equipment state captured at point of event; CAPA initiated directly from deviation record with full data linkage; deviation data aggregated continuously for trend analysis and proactive escalation.
Used by biopharmaceutical and life sciences operations teams to automate batch workflows, maintain GMP data integrity, and scale digital initiatives beyond the pilot on top of Node-RED
Ready to see your batch operations in one view?
Share a sample of your instrument estate and production workflows and the team will show how FlowFuse would connect, automate, and manage your operations in real time.
