Leucine’s Manufacturing Execution System (MES) is purpose-built for pharmaceutical manufacturers to digitize, standardize, and optimize batch execution across all production units. With built-in GMP compliance and seamless shop floor integration, Leucine MES enables real-time decision-making, faster batch releases, and full traceability—empowering your teams to deliver with confidence.
Key Features
Electronic Batch Records (eBMR): Digitize your batch execution with structured, compliant, and validated records.
Dynamic Workflows: Configure workflows that mirror your exact SOPs, enabling easy adoption and continuous improvement.
Real-Time Shop Floor Monitoring: Gain live visibility into production status, bottlenecks, and deviations.
Equipment & Material Traceability: Track every input, every action, and every output—across people, equipment, and materials.
Audit-Ready, Always: Built-in compliance with FDA 21 CFR Part 11, EU Annex 11, and WHO TRS standards.
Seamless Integrations: Plug into your existing ecosystem—ERP, QMS, LIMS—for end-to-end digital continuity.
Business Impact
Accelerate Batch Releases with zero paper and faster reviews
Reduce Errors & Deviations through structured, guided execution
Boost Productivity with real-time coordination and shop floor digitization
Ensure Global Compliance with built-in regulatory best practices