Compliant & Audit-ready
drug manufacturing for pharma
Manufacture significantly more batches with bulletproof compliance
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Preferred by progressive pharma enterprises
4 out of top 10 global generics pharma use Leucine
250+ sites
Using Leucine Platform globally
36% faster
Batch Manufacturing
6 weeks
Rapid Go-Live
One platform for end-to-end compliance
Purpose built use cases for Quality Assurance, Manufacturing and Quality Control
DIGITAL WORK INSTRUCTIONS
Self-enforcing Digital Workflows for all teams
No-Code Process Builder transforms your paper-based procedures rapidly into digitally signed, self-executing work instructions that leverage digitally captured data and verifiable process workflow.
Collaboratively Review & Release the work instructions before they become effective and available for GxP execution. Revising the work instructions for changing business needs is a breeze on the Leucine platform.
Built-in Compliance Protocols ensure that your process specific cGMP regulations are met and your procedural controls are self-enforced by design.
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REAL-TIME PROCESS MONITORING
Ensure proactive compliance via real-time monitoring & interlocks
Live tracking: of ongoing work instructions on a single pane of glass for Supervisors and Managers who can monitor them in real-time and intervene whenever necessary. Escalations happen proactively to ensure that compliance & efficiency benchmarks are not breached.
Review by Exception: Supervisors consume auto-generated Job Summary Reports that highlight relevant exceptions and efficiency metrics, and enable review-by-exception.
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UNIFIED FACILITY ANALYTICS
Analyze efficiency & quality of your regulated processes
Digital Transparency via facility-level dashboards across various aspects like Live Tracking, Durations, Exceptions and Critical Process Parameters. Identify trends of time & resources it takes to perform critical processes such as manufacturing, changeover, sampling, and more.
Benchmarking: All processes are benchmarked automatically using built-in algorithms. This ensures that your plants are running close to the design capacity, leading to higher manufacturing opportunity.
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One platform for end-to-end
compliant manufacturing
MANUFACTURING
Plan, execute & monitor batches from a single pane
Manufacturing teams can perform the end-to-end workflows for a batch such as building recipes using Leucine No-code process builder, planning & execution of the batch, Monitoring the batch progress in real time, and, releasing the batch via automated workflows.
Batch planning & execution: Schedule Batches for weeks and months on top of ongoing batches. Dynamic suggestions like rescheduling batches based on current operations and events like Equipment Breakdowns.
Monitoring ongoing batches: Supervisors track all Stages of multiple products in real-time. Exceptions like Equipment Break Down, delays, deviations get notified for easier intervention
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QUALITY ASSURANCE
Review & Release batches faster with integrated QA workflows & data
Central mechanism that logs all process & quality events for a batch.
Integrated Quality Workflows: Ensure the process & product quality by performing built-in compliance interlocks and associated workflows such as In-process Quality Checks, Line/Area Clearance, and, Batch release checklists.
Faster deviation logging & closure: Process & quality deviations are auto generated, notified to the authorized QA personnel, and if required, logged into a QMS system. Ready-to-use analytics assists in resolving the deviations faster than ever.
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QUALITY CONTROL
Modernize your sample test procedures for faster & reliable analysis
Your Quality Control Analysits will perform the test procedures using the Leucine platform.
Build digital test instructions: author your paper-based sample analysis procedures rapidly into digitally signed, self-executing work instructions that leverage digitally captured data and verifiable process workflow.
OOS Investigations: Narrow down your OOS investigations with an auto-generated event log that correlates any OOS events with potential root causes.
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