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Hercule

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(1)5.0/5

Hercule is an on-premise biomanufacturing data platform for biotech and CDMOs. Electronic batch records, CPV automation, DoE, and ML modelling in one GMP-validated system — deployable in weeks, on your own server. In more details : Hercule is a biomanufacturing data management and analytics platform built for biotechs (from development- to commercial-stage) and CDMOs. It runs on-premise on your own Linux server (Docker), keeping your process data inside your perimeter — no cloud dependency, no data sovereignty compromise. Electronic batch records (eBR): Hercule's form editor lets you build ISA S88-structured batch records with embedded operator instructions, mandatory sign-off, and a dedicated validator role. Every parameter captured is semantically typed against the process hierarchy from the moment of entry — not mapped after the fact. A custom batch release report with sign-off panel is generated per batch from the CPV module. Continued Process Verification (CPV): Automated CPV against limits of specification, trends, and golden batch benchmarks. Critically, an out-of-spec value confirmed during a running batch triggers a CPV alarm in real time — before the batch is complete. This is possible because the batch record and the analytics engine are one system, not two integrated modules. Process analytics and ML: DoE (Design of Experiments), multivariate modelling, process optimisation, and federated learning across sites via vantage6 — all working on the same ISA S88-structured dataset. Compliance: GAMP5 V2, 21 CFR Part 11, Keycloak authentication, full audit trail, Trivy-scanned Docker images. Data model: Hercule-CDM — 200+ biomanufacturing concepts structured to ISA S88, covering the full process lifecycle. CPP, CQA, and actionable metadata are baked in at capture, making every dataset immediately ML-ready without a data engineering project. Every batch you run without structured data capture is knowledge you will never recover. Hercule gives you the data infrastructure that turns your manufacturing history into a competitive asset — starting in weeks, not years.

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