LeucineOS
Agentic Platform for
Pharma Manufacturing
AI Applications for Quality, Manufacturing and Compliance — purpose-built agents that automate deviation handling, streamline batch review, and keep you audit-ready around the clock.
LeucinOS Applications
Purpose-built applications powered by AI to streamline every aspect of pharmaceutical operations.
Documents
Full lifecycle document control with AI-generated SOPs, automated compliance checks against regulatory standards, intelligent review routing, and version management with 21 CFR Part 11 e-signatures.
Learning
AI-generated training content from your SOPs, personalized learning paths based on role and skill gaps, auto-triggered assignments on document changes, and competency tracking with smart re-certification scheduling.
Audits
AI-generated audit checklists from regulatory guidelines, predictive risk scoring to prioritize inspections, automated evidence collection across systems, and real-time readiness dashboards that surface gaps before auditors do.
Deviations
AI-powered root cause analysis that learns from historical data, automatic deviation classification and severity scoring, predictive trending to prevent recurrence, and smart escalation routing based on impact assessment.
Changes
AI-driven impact assessment that maps ripple effects across documents, training, and equipment. Auto-generated implementation plans, intelligent approval routing, and regulatory change classification to keep you compliant through every transition.
Corrections
AI-recommended corrective actions drawn from similar past events, automated effectiveness verification scheduling, predictive analytics to flag systemic issues before they escalate, and full traceability linking CAPAs to deviations, audits, and complaints.
Complaints
AI-powered triage that auto-categorizes and scores incoming complaints, intelligent signal detection across complaint patterns, auto-generated investigation reports, and streamlined adverse event reporting to regulatory bodies.
Environment
Continuous environmental monitoring with AI-predicted excursions before limits are breached, automated viable and non-viable trending, smart alert thresholds that adapt to seasonal patterns, and auto-triggered deviation workflows on out-of-spec events.
Samples
Full sample lifecycle from collection to disposition with AI-optimized testing schedules, automated disposition recommendations based on results, chain-of-custody tracking, and intelligent stability program management with predictive shelf-life analysis.
Risks
AI-assisted risk identification that surfaces hidden patterns across quality events, automated FMEA scoring, dynamic risk heat maps that update in real-time, and predictive modeling that quantifies risk impact before it materializes.
Suppliers
AI-powered supplier risk scoring from performance data and audit history, automated qualification workflows, predictive quality issue detection based on delivery and inspection trends, and real-time scorecards with intelligent re-evaluation triggers.
Point solutions don't talk to each other.
That silence costs you.
Your batch record system doesn't know about your training records. Your deviation system can't see your SOP library. Your cleaning validation doesn't gate your batch execution. Every gap between systems is a compliance risk — and a missed opportunity for AI.
1 data model
Shared Ontology
Every application shares one data model. A 'batch' in Batch Execution is the same entity in Root Cause Investigator, Yield Optimizer, and Batch Record Reviewer. This isn't an integration — it's an architecture.
38+ live connections
Signal Architecture
Events in one application automatically trigger actions, share data, or gate operations in others. An SOP revision auto-assigns training. A cleaning expiry blocks batch start. A deviation triggers AI investigation. No human had to remember.
5 AI agents
AI on Complete Data
The Yield Optimizer sees batch parameters AND material properties AND equipment maintenance AND environmental conditions. The SOP Gap Analyzer reads SOPs AND compares against execution data. AI on a fragment is a tool. AI on the full picture is intelligence.
Every app talks to every other
Click any app to see how signals flow across the platform.
AI-driven
Compliance Superiority
AI agents in LeucineOS continuously monitor, connect, and act on signals across your operations — orchestrating every process toward airtight compliance without manual overhead.
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Training Lifecycle
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Execute
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Periodic Review
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Real-world Use Cases
Explore how our AI transforms pharmaceutical manufacturing operations across quality, manufacturing, and regulatory workflows.
Put AI agents to work across your quality, manufacturing, and compliance operations — from deviation handling and batch review to audit readiness and regulatory submissions. LeucineOS replaces siloed point solutions with one intelligent platform that automates what slows you down and surfaces what matters most.
