Leucine
AI-Powered Platform for Pharma Manufacturing.
Overview
Leucine provides an AI-powered Electronic Batch Record (EBR) software designed to help pharmaceutical manufacturers optimize batch manufacturing, ensure compliance, and reduce deviations. The platform covers the entire production workflow, from weighing to release, and ensures compliance with FDA 21 CFR Part 11 and EU Annex 11.
✨ Key Features
- Electronic Batch Records (eBMR)
- AI-Powered GMP Enforcement
- Digital Work Instructions
- Automated Audit Trails
- Electronic Signatures
- Batch Traceability
🎯 Key Differentiators
- AI-powered features for compliance and deviation reduction
- Modern, user-friendly interface for shop floor execution
- Unified platform for all batch record functions
Unique Value: Uses AI to optimize every step of batch manufacturing, ensuring compliance and minimizing deviations in a single, unified platform.
🎯 Use Cases (3)
✅ Best For
- Used by pharmaceutical manufacturers to replace paper systems with secure digital workflows.
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Not a full QMS; primarily focused on manufacturing execution and batch records.
🏆 Alternatives
Offers advanced, AI-driven capabilities for proactive compliance and process optimization that traditional EBR systems lack.
💻 Platforms
✅ Offline Mode Available
🔌 Integrations
🛟 Support Options
- ✓ Email Support
- ✓ Live Chat
- ✓ Phone Support
- ✓ Dedicated Support (Varies tier)
🔒 Compliance & Security
💰 Pricing
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