Elevate Deviation Management to
Meet FDA and Global Pharma Standards

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How It Works?

Automate, analyze, and address deviations with precision and compliance, ensuring product integrity and patient safety.

Automated location-based scheduling

Automatically adjust monitoring schedules based on real-time production activity
Leverages facility layout and risk data to prioritize sampling in high-risk areas

Trend analysis with advanced analytics and visualization tools

Analyze complex data in real-time to avoid potential compliance risks
Visualize critical trends and anomalies against in-house library of microbes

Generate release certificates and audit-ready reports

Automatically integrate data from various monitoring points to generate audit-ready reports
Create Release Certificates with one-click

Automated Deviation Detection and Documentation

Automatically detect and document deviations in real-time, ensuring rapid response and compliance with Good Manufacturing Practices (GMP).
Our system initiates a documented workflow as soon as deviations are identified, guaranteeing immediate and transparent communication across relevant departments.

Automated RCA Using Standard Risk Methodologies

Utilize established RCA techniques such as the Five Whys and Fishbone Diagrams, integrated within our platform, to thoroughly investigate and determine the underlying causes of deviations.
Our AI-driven analysis helps pinpoint the origin quickly and accurately, supporting effective resolution strategies

CAPA Recommendations Aligned with FDA Guidelines

Develop and deploy corrective and preventive actions based on a risk management framework aligned with ICH Q9 guidelines.
Our system helps you prioritize CAPA activities based on their impact on product quality and compliance, ensuring efficient resource utilization and enhanced process control

Efficient CAPA Implementation and Monitoring

Execute CAPAs with rigorous adherence to predefined protocols.
Leucine 10x provides tools for monitoring the implementation and effectiveness of each action, with continuous feedback loops that confirm the sustainability of improvements and compliance with industry standards

Streamlined Effectiveness Review and Audit Preparation

Conduct detailed reviews to assess the effectiveness of all actions taken against deviations.
Our platform ensures that all documentation is complete and audit-ready, facilitating smooth closure of deviation cases and preparing your operations for regulatory inspections.

Continuous Improvement Through Data Analytics

Leverage insights derived from deviation management processes to foster continuous improvement across your manufacturing operations.
Our analytics capabilities help you identify trends and areas for enhancement, ensuring ongoing compliance and quality optimization.

Trusted by 350+ Pharmaceutical

Manufacturing Facilities Around the World

Trusted by 300+  

Pharmaceutical Manufacturing

Facilities Around the World

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Elevate Deviation Management

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