AI-Powered Electronic Batch Record Software
Optimize every step of batch manufacturing, from weighing to release while ensuring compliance, minimizing deviations, and accelerating production. Deliver Batches On Time, In Full.
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The first predictive EBR Software that eliminates bottlenecks before they happen
Minimize Batch Start Delays
Ensure all production inputs—materials, equipment, and personnel—are verified and ready with automated production readiness checks, reducing unplanned stoppages.
Reduce Process Deviations
Enforce process interlocks, real-time alerts, and guided workflows to eliminate execution errors and ensure first-time-right batch.
Expedite Batch Release
Digitally capture batch records, automate exception tracking, and streamline review processes to accelerate compliance and reduce release cycle times.
Ensure accurate material dispensing with ERP & Balance Integration
Monitor Equipment and Area Readiness to start batches without delay
Standardize Batch Execution. Reduce Deviations & GDP Errors.
Track WIP inventory across the shop floor in real-time.
Auto capture data via L2 Integrations and Computer Vision
Monitor your Facility and ensure compliance
Always audit-ready with digital records.
Frequently Asked Questions
Can I trial Webflow before paying?
Sure! You can test out Webflow on our free plan where you can experiment with 2 projects. Your unhosted projects will have a two-page limit, but you can purchase a site plan on a per-project basis to unlock up to 100 static pages and additional CMS pages.
What is a project?
A project is a website that you build in Webflow. You can publish projects to a webflow.io staging subdomain for free, export the code on a paid plan, or add a site plan to connect your custom domain and unlock hosting features.
What can I white label?
Pro accounts can add their own logo to Client Billing forms and the Editor. Pro accounts can also remove references to Webflow in the source code and form submission emails, and hide the Webflow badge from their staging sites.
Frequently Asked Questions
How does Leucine's Electronic Batch Record (EBR) software improve compliance and data integrity?
Leucines integrated EBR system helps ensure compliance with regulatory standards like FDA 21 CFR Part 11 and EU Annex 11. It replaces paper-based systems with secure electronic records, supports incorporating electronic signatures, and enforces good manufacturing practices. This improves data integrity, enhances product quality, and reduces overall compliance costs in pharmaceutical manufacturing.
How does Leucine's EBMR help with batch traceability?
Leucine's EBR system digitally document every step of the batch manufacturing and production process, from raw materials to final output. The system then links master batch records, equipment, and personnel actions to provide full traceability. This ensures regulatory bodies can audit the manufacturing process with ease and confidence.
How does Leucine's electronic batch record help reduce batch release times?
By replacing paper-based systems with digital workflows, Leucine's EBR systems speed up batch production and exception handling. Real-time capture of quality data, automated compliance checks, and electronic signatures accelerate approvals—leading to faster, GMP-compliant batch releases for pharmaceutical manufatureres.
Is Leucine’s electronic batch manufacturing record system compatible with ERP and MES systems?
Yes, Leucine’s modular design supports seamless integration with ERP, MES, QMS, and LIMS platforms. This enables synchronized data flow, streamlines manufacturing processes, and improves visibility and process efficiency across all systems.
Can Leucine’s eBMR system help reduce manufacturing costs?
Absolutely. EBR software reduces errors, automates documentation, and improves process efficiency, lowering compliance costs and increasing quality. It's a significant step toward leaner operations in pharmaceutical manufacturing and medical devices production.
View and learn more about Batch Manufacturing Execution with our comprehensive list of resources
Pharma 4.0: Leading Digital Transformation in Pharmaceutical Manufacturing
Explore essential insights for navigating Pharma 4.0 and driving future success in the pharmaceutical industry. Read the article now for key strategies.
The Ultimate Guide to Batch Manufacturing – White Paper 2025
Download Leucine's 2025 white paper on FDA batch manufacturing. Learn top 483 trends, best practices & AI tools to stay inspection-ready.
Most Common FDA 483 Observations on Batch Release
Discover the most common FDA 483 observations on batch release and learn key corrective and preventive actions to ensure compliance and avoid audit risks.
Most Common FDA 483 Observations on Batch Records
Explore the top FDA 483 observations on batch records and discover corrective actions to strengthen compliance, avoid citations, and stay inspection-ready.
Unlocking Pharma MES for Modern Manufacturing Excellence
Discover how Pharma MES transforms batch execution, ensures regulatory compliance, and accelerates product release in modern pharmaceutical manufacturing.
How Electronic Batch Record systems are transforming Pharma Manufacturing
Discover the advantages of electronic batch records and learn best practices to enhance compliance and efficiency in your processes. Read more now!
Batch Production in Pharmaceuticals - Strategic Excellence Through Innovation
Discover the key benefits and challenges of batch production along with practical applications to enhance efficiency. Read the article to learn more!
Master Batch Record in Pharma
Discover how a master batch record ensures GMP compliance, process consistency, and quality in pharma manufacturing with Leucine’s digital MBR toolkit.
Batch Manufacturing Record in Pharmaceutical manufacturing process
Discover best practices and essential tips for creating effective batch manufacturing records. Enhance compliance and efficiency—read the guide now!
A Complete Guide to Elogbook in Pharmaceutical Manufacturing
Explore how paperless elogbooks and electronic logbook software improve compliance, data integrity, and efficiency in pharma and life sciences operations.
Top FDA 483 Observations in Batch Manufacturing
Analyze top FDA 483 observations in batch manufacturing, including root causes, corrective actions, and preventive measures to ensure compliance.
Electronic Batch Manufacturing - Audit Readiness Checklist
Ensure compliance with our audit readiness checklist for electronic batch manufacturing. Covers documentation, validation, training, and continuous improvement.
Batch Manufacturing Record Guidelines in the Pharmaceutical Industry
Comprehensive Batch Manufacturing Records Guidelines: Ensuring Pharma Compliance, Quality Control, and Regulatory Adherence
Batch Record: A Detailed Guide on Batch Manufacturing & Electronic Batch Records
Learn how to optimize production with an essential guide to batch records. Discover best practices and improve efficiency in your processes. Read more!
Experience AI-Powered Electronic Batch Records with Leucine
Join leading pharmaceutical companies in transforming batch execution. Ensure regulatory compliance, reduce deviations and accelerate batch release—all with one intelligent solution.
Have a look at our other suite of MES Essentials to 10x your process
Batch Recipe Designer
Digitize, configure, and streamline batch recipes effortlessly.
Logbooks
Digitize your logbooks for Data Integrity & SOP Adherance
Shop Floor Monitor
Monitor Facility Operations
Batch Release
Expedite Batch Release
Material Management
Manage Inventory and Equipment.
Batch Execution
Activate paperless production.
