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Experience Leucine AI.
‍Powered Pharma Operations

Transform Your Pharma Operations with AI-Powered Intelligence. Experience how Leucine's integrated platform brings together manufacturing, quality, and laboratory operations in one digital ecosystem. Schedule a personalized demo to see how our AI solutions can optimize your processes, ensure compliance, and drive operational excellence.

See How AI Transforms Your Shop Floor Operations.
Experience firsthand how Leucine's 10x MES digitalizes batch records, streamlines production, and provides real-time monitoring of your manufacturing operations. Schedule a personalized demo to discover how our AI-powered platform can enhance your productivity while maintaining compliance.

Experience AI-Driven Quality Management in Action.
See how Leucine's 10x QMS automates compliance workflows, streamlines change control, and ensures regulatory adherence. Schedule a demo to learn how our AI-powered platform can help you manage quality processes more efficiently while reducing compliance risks.

Discover Smart Laboratory Operations Management.
Watch how Leucine's 10x LES orchestrates your lab operations, automates documentation, and ensures data integrity. Schedule a demo to see how our AI-powered platform can accelerate your testing processes while maintaining audit-readiness.

Optimize your manufacturing processes with paperless operations
Strengthen quality management and regulatory compliance
Accelerate laboratory operations and testing workflows

Connect with a Leucine Expert

Schedule a 30-Minute Product Demo with Expert Q&A

Experience the future

of Pharma Manufacturing.

Plan, execute, and optimize every batch. Deliver On Time In Full with AI-powered pharma manufacturing & compliance intelligence.

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Manufacturing
Quality
Laboratory

Integrated Platform to Plan, Execute, and Optimize Every Batch—On Time, In Full.

Track every batch from planning to release—identify constraints, detect bottlenecks, and take proactive actions to eliminate delays.

Manufacturing
Optimize production with AI-powered batch execution, real-time OTIF tracking, and production logbooks.
Quality
Accelerate investigations, enforce compliance, and automate validation with AI-driven tools.
Laboratory
Enhance lab efficiency with automated environmental monitoring and intelligent instrument management.
Manufacturing
Optimize production with AI-powered batch execution, real-time OTIF tracking, and production logbooks.
Quality
Accelerate investigations, enforce compliance, and automate validation with AI-driven tools.
Laboratory
Enhance lab efficiency with automated environmental monitoring and intelligent instrument management.
Navigating FDA
Observations in 2025
This white paper provides actionable insights into the regulatory expectations, observations & AI-powered strategies to mitigate compliance reactions.
Download White Paper

Manufacturing
Execution System

Optimize every step of production, from material dispensing to final batch release.

Batch Execution
Digitize and Standardize Manufacturing Workflows.Ensure accurate material dispensing, enforce process interlocks, and capture real-time execution data for error-free batches.
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Batch Intelligence
Monitor production in real-time, detect potential delays early, and take proactive corrective actions to optimize efficiency.
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Production Logbooks
Digitally capture cleaning and usage logs, maintenance records, and changeovers to ensure a seamless, audit-ready production process.
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Expedite Batch Release
Streamline your batch record review process with an exception-based approach that accelerates approvals, improves accuracy, and ensures regulatory compliance.
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Monitor your Facility,
at a Glance
Gain real-time visibility into your facility’s operations with shop floor software. Access comprehensive insights into equipment status, batch progress, and process efficiency to optimize shop floor management.
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Track WIP Inventory Down to the Last Unit
Gain real-time visibility and control over your WIP inventory with advanced material management software for precise operations.
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Quality
Management System

Ensure seamless regulatory compliance and quality excellence with AI-driven quality solutions.

Resolve Market Complaints Faster
Automate triage with global regulatory compliance while ensuring swift and accurate compliant handling.
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Accelerate Insights, Elevate Compliance
Leverage AI with advanced investigation capability to transform complex and time-consuming processes into audit-ready workflows.
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Analyze FDA 483s & Stay Audit Ready
Access detailed insights into FDA 483 observations and warning letters which supports audit readiness and compliance.
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Enable Error-free Cleaning Validation
Establish safe carryover limits to perform worst-case evaluations, manage change assessments and automate cleaning validation as per FDA's cleaning validation guidelines.
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Download a comprehensive Solution white Paper and ensure you're fully prepared for FDA inspections.
Download Case Study
Read Article
AI Investigator
Leverage AI-powered root cause analysis and CAPA recommendations to drive consistent, science-based investigations.
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FDA Tracker
Analyze FDA 483 trends, monitor warning letters, and proactively address regulatory gaps to ensure inspection readiness.
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Cleaning Validation
Calculate safe carryover limits, track residue trends in real-time, and generate audit-ready validation reports effortlessly.
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Unlock Tangible Benefits with Leucine

Track every batch from planning to release—identify constraints, detect bottlenecks, and take proactive actions to eliminate delays.

Reduce Batch Delays
Identify and resolve production bottlenecks in real time. Proactively mitigate risks to ensure seamless execution.
Reduce Cost of Quality
Minimize deviations, improve compliance efficiency, and prevent costly rework with AI-driven process controls.
Improve OTIF Performance
Optimize planning, execution, and release cycles to consistently deliver batches On Time, In Full.
Experience Leucine AI Powered pharma manufacturing
Request Consultation
300+ pharma facilities worldwide use Leucine to stay compliant. Talk to one of our expert consultants at Leucine to learn how.
MES software ESSENTIALS

Have a look at our other suite of MES Essentials to 10x your process

Cleaning Validation

Validate Cleaning

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Investigator Writer

Streamline Investigations

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FDA Tracker

Track FDA Actions

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Market Compliant Manager

Market Compliant

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Experience the Future
of Pharma Manufacturing.

Products

FDA Compliance Tools

Blogs & White Papers

MES - Excellence HubQMS - Excellence HubCleaning Validation - Excellence Hub

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