Quality systems record.
AI-QMS acts.
One shared data model across every quality workflow. Signals that trigger actions automatically. Agents that act on complete information, not fragments from disconnected point solutions.
LeucineOS Applications
Purpose-built applications powered by AI for every aspect of pharmaceutical quality and manufacturing.
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.
Explore Documents
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.
Cipla: 8,000+ credentialed staff trained across 30 facilities
Explore Learning
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.
Piramal: 100% 21 CFR Part 11 compliance across 3 regulatory jurisdictions
Explore Audits
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.
Cipla: deviations and CAPA live across 30 sites on one audit trail
Explore Deviations
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.
Explore Changes
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.
Explore Corrections
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.
Explore Complaints
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.
Explore Environment
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.
Explore Samples
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.
Explore Risks
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.
Explore Suppliers
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 continuous compliance without manual overhead.
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Review
HITLhuman-in-the-loop
Approve
HITLhuman-in-the-loop
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Training Lifecycle
Assign
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Execute
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AI Capabilities
Real-world Use Cases
Explore how our AI transforms pharmaceutical manufacturing operations across quality, manufacturing, and regulatory workflows.
Built for inspection
Compliance is the architecture, not a feature bolted on.
One shared data model means one audit trail across every workflow. Data integrity holds by design, so you walk into inspection with the evidence already in order.
21 CFR Part 11
Every action electronically signed, timestamped, and traceable. Tamper-evident audit trails on every record.
ALCOA+ by design
Attributable, legible, contemporaneous, original, accurate. One ontology means one audit trail, not eleven.
Security and access
Role-based access, SSO, and segregation of duties in validated environments built for GxP.
Proven in inspection
Piramal runs 10+ facilities at 100% 21 CFR Part 11 from day one, harmonised across FDA, MHRA, and EMA.
Proven at Scale
Running in production at 400+ GMP facilities
New Jersey, USA
Automated HBEL-based cleaning validation with risk-based protocol generation, ensuring continuous FDA and EMA compliance.
Impact studies
Top pharma manufacturers. Large scale deployments.
From the world's largest paperless deployment to multi-jurisdiction harmonisation: what changed when quality and production moved onto one AI-native 21 CFR Part 11 platform.
Down from 20, with 2,700 hours saved annually and 60% fewer manual data entries.
Read the impact study CiplaAcross 30 sites and 8,000+ credentialed staff. World's largest paperless manufacturing deployment.
Read the impact study Piramal PharmaFDA, MHRA and EMA on one standard. 100% 21 CFR Part 11 from day one.
Read the impact studyDeployment
Live in weeks, not years.
Start with one site, prove it, then scale across the network on the same platform. A 100% go-live record across 400+ GMP facilities.
Stand up one site and one workflow on validated infrastructure. Operators trained on the floor, not in a classroom. See real quality events close faster before you commit the network.
- One site, one workflow, live in 8 weeks
- On-ground solution architecting at your facility
- 21 CFR Part 11 records from day one
FAQ
Questions buyers ask.
Is LeucineOS 21 CFR Part 11 compliant?
Yes. Electronic signatures, tamper-evident audit trails, and access controls are built into every app. Because all apps share one data model, you get a single consistent audit trail across quality, manufacturing, and compliance, not eleven disconnected ones.
How does LeucineOS integrate with our existing MES, LIMS, and ERP?
LeucineOS connects to your existing systems rather than replacing them. Standard connectors and APIs let data flow in and out, so it sits on your stack and closes the gaps between point solutions.
Can it deploy across multiple sites and regulatory jurisdictions?
Yes. Piramal runs 10+ facilities on one standard, harmonised across FDA, MHRA, and EMA. You roll out site by site on the same platform, with data shared across facilities instead of siloed per site.
How long does implementation take?
Most customers see a first site live in 8 to 12 weeks. A pre-executed GAMP 5 CSV package, configuration, and training are included, and every rollout to date has gone live successfully.
Does LeucineOS replace our point solutions or work alongside them?
Either. Many customers start by connecting LeucineOS to existing tools, then consolidate onto it over time as they see the value of one platform running on shared data.
Get started
See your deviations close themselves and every site stay inspection ready.
Book a 30-minute walkthrough on your own products and sites. We will show deviation handling, batch review, and audit readiness running on data like yours. No commitment, no sales pitch.