Leucine MES
Plan, execute, and optimize every batch.
Deliver On Time In Full with AI-powered
batch manufacturing & compliance intelligence.
Built for Regulated Shop Floors
Every module purpose-built for regulated manufacturing — from batch design to global rollout.
Leucine MES digitises your entire production floor into a single connected workspace. Batch execution, material dispensing, equipment management, and electronic logbooks — with real-time visibility, paperless compliance, and faster batch release built in.
Download Leucine MES Preview →Compliant-first Execution
A batch execution workflow engine where compliance is the default, not an afterthought. Every step, every signature, every parameter check is guided, enforced, and recorded — so your operators focus on production while the system ensures GMP adherence.
Guided Digital Workflows.
Replace paper batch records with step-by-step digital instructions that operators follow on the shop floor.
Electronic Signatures.
Full 21 CFR Part 11 compliant e-signatures at every critical step, with automatic identity verification.
In-Process Checks.
Automatic parameter checks and limit enforcement ensure every value is within specification before the batch proceeds.
Review by Exception.
Only review what deviates from the norm — accelerating batch release by up to 3x.
MBR Design
Design and configure Master Batch Records with a visual editor. Define process steps, parameters, materials, and approval workflows — then deploy across products and sites.
Visual Batch Record Builder.
Drag-and-drop interface to design process steps, parameters, and material requirements without code.
Reusable Templates.
Create once, deploy across products and dosage forms — with version control and full audit trail.
Approval Workflows.
Configurable multi-level review and approval workflows before any record goes live on the shop floor.
Cross-Site Deployment.
Push approved records to multiple manufacturing sites with locale-specific overrides where needed.
Process Interlocks
Built-in compliance locks powered by FDA intelligence. Leucine MES prevents out-of-sequence execution, enforces hold points, and blocks non-compliant actions before they happen.
Sequence Enforcement.
Prevent out-of-order operations — operators cannot skip or rearrange steps that the batch record defines.
Hold Points.
Configurable mandatory hold points that pause execution until supervisory review or QA sign-off.
Verification Gates.
Material and equipment verification at every critical handoff — barcode-scanned and system-confirmed.
Real-Time Visibility.
Live interlock status across all active batches so supervisors know exactly where every batch stands.
Ontology
A common data model that unifies every process — batch manufacturing runs, materials, equipment, and quality events — into a single connected graph. Query anything, trace everything, and build intelligence across your entire operation.
Unified Data Graph.
Every manufacturing entity — batches, materials, equipment, quality events — connected in a single queryable model.
Full Batch Genealogy.
Trace any finished product back through every material, process step, and operator that touched it.
Cross-Entity Search.
Ask questions across your entire operation — find every batch that used a specific raw material lot in seconds.
AI-Ready Foundation.
A structured data layer that powers Cortex analytics, predictions, and recommendations.
Global Deployments
Deploy across sites worldwide with built-in internationalisation and localisation. Multi-language interfaces, locale-specific units and formats, and region-aware regulatory configurations — ready for every market you operate in.
Multi-Language Interfaces.
Operator interfaces available in local languages out of the box — no custom translation layer needed.
Locale-Specific Formats.
Units, date formats, number conventions, and measurement standards adapt to each site's locale.
Region-Aware Compliance.
Regulatory configurations that reflect local GMP requirements — FDA, EMA, ANVISA, and more.
Centralised Control.
Manage templates and configurations centrally with the ability to apply local overrides per site.
Cortex
Autonomous AI agents that reason over your manufacturing data — and act on it.
Cortex deploys goal-oriented AI agents directly on top of your Leucine MES data. Each agent is equipped with domain-specific skills and accesses your batch records, process parameters, equipment data, and quality events through standardised MCP tools — turning raw manufacturing intelligence into decisions you can trust.
Agents don't replace your team. They augment it — surfacing the insight that matters, at the moment it matters, with full traceability back to the data that informed it.
Compliance Agent
Continuously monitors batch execution against GMP requirements and regulatory expectations. Flags deviations before they escalate, surfaces review-by-exception candidates, and pre-populates investigation reports.
Yield Optimization Agent
Analyses process parameters across thousands of historical batches to identify the conditions that produce the best outcomes. Recommends real-time parameter adjustments and predicts batch yield before completion.
Efficiency Agent
Optimises batch scheduling, predicts equipment bottlenecks, and reduces cycle times across production lines. Identifies idle time patterns, recommends changeover sequences, and forecasts throughput impact.
Skills-Based Architecture.
Each agent is composed of modular skills — discrete capabilities like deviation detection, parameter correlation, or schedule optimisation — that can be assembled and configured without code.
MCP Tool Access.
Agents connect to your MES data through standardised Model Context Protocol tools — batch records, process parameters, equipment status, material genealogy, and quality events — with full audit trail on every data access.
Goal-Oriented Execution.
Define the objective — reduce right-first-time failures, improve OEE, or accelerate batch release — and the agent plans and executes a strategy to get there, reporting progress at every step.
Human-in-the-Loop.
Every agent recommendation flows through configurable approval workflows. Agents advise, humans decide — maintaining full regulatory accountability and 21 CFR Part 11 compliance on every action.
Cortex Agent Console
Cortex Agent Demo
See how AI agents reason over your manufacturing data in real time.
L2 Integrations
Connect Leucine MES with your existing automation layer — PLCs, SCADA, historians, and equipment interfaces.
Production-grade connectivity from shop floor to cloud — out of the box.
Every connector, gateway, and cloud pipeline ships ready to deploy — no custom middleware, no integration projects. Leucine MES plugs directly into your existing automation layer so you can go live faster and trust the data flowing into your batch records.
Edge Gateway Connectors.
Protocol-specific connectors for OPC-UA, Modbus TCP, MQTT, PI/Historian, Serial RS-232, and REST/SOAP — translating and buffering data at the edge.
Azure Cloud Pipeline.
Centralised data pipeline through Azure IoT Hub, Stream Analytics, and Time Series Insights for real-time telemetry ingestion and storage.
Configuration Portal.
Web-based interface to manage device registries, tag mappings, protocol configurations, alert rules, and connection health monitoring.
Real-Time Equipment Data.
Live process values, equipment status, and sensor readings flow directly into batch records, interlocks, and the electronic logbook.
Use Cases
See how Leucine MES transforms batch manufacturing across pharma production workflows.
Leucine MES brings your entire production floor into a single digital workspace — from batch execution and material dispensing to equipment management and electronic logbooks — giving you real-time visibility, paperless compliance, and faster batch release.
