Leucine - No-code platform for fast & compliant drug manufacturing

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

Leucine ensures 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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With Leucine you can analyse efficiency & quality of your regulated processes

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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Compliant & Audit-readydrug manufacturing for pharma

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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Compliant & Audit-ready
drug manufacturing for pharma

Preferred by progressive pharma enterprises

One platform for end-to-end compliance

DIGITAL WORK INSTRUCTIONS

Self-enforcing Digital Workflows for all teams

REAL-TIME PROCESS MONITORING

Ensure proactive compliance via real-time monitoring & interlocks

UNIFIED FACILITY ANALYTICS

Analyze efficiency & quality of your regulated processes

CAPABILITIES

USE CASES

ABOUT

One platform for end-to-end
compliant manufacturing

MANUFACTURING

Plan, execute & monitor batches from a single pane

QUALITY ASSURANCE

Review & Release batches faster with integrated QA workflows & data

QUALITY CONTROL

Modernize your sample test procedures for faster & reliable analysis

Compliant & Audit-readydrug manufacturing for pharma

Preferred by progressive pharma enterprises

One platform for end-to-end compliance

DIGITAL WORK INSTRUCTIONS

Self-enforcing Digital Workflows for all teams

REAL-TIME PROCESS MONITORING

Ensure proactive compliance via real-time monitoring & interlocks

UNIFIED FACILITY ANALYTICS

Analyze efficiency & quality of your regulated processes

CAPABILITIES

USE CASES

ABOUT

One platform for end-to-endcompliant manufacturing

MANUFACTURING

Plan, execute & monitor batches from a single pane

QUALITY ASSURANCE

Review & Release batches faster with integrated QA workflows & data

QUALITY CONTROL

Modernize your sample test procedures for faster & reliable analysis

Compliant & Audit-ready
drug manufacturing for pharma

One platform for end-to-end
compliant manufacturing