Investigation Writer

Accelerate Insights, Elevate Compliance

Investigation Writer empowers pharmaceutical companies to revolutionise the way they approach out-of-specification investigations. By leveraging AI, it transforms complex, time-consuming processes into audit-ready workflows. Designed to ensure compliance & operational excellence, Investigation Writer sets a new standard in pharma quality management.

How it Works?

Faster Investigations

Close investigations quickly with AI-guided workflows, reducing manual effort and enabling timely batch releases.

Improved Quality

Achieve thorough root cause analysis with guided workflows that ensure comprehensive, high-quality investigations.

Compliance Simplified

Stay aligned with FDA standards through AI-powered verification, producing audit-ready documentation effortlessly.

Fewer Recurring Issues

Leverage AI to uncover patterns and prevent recurring deviations, ensuring sustainable quality improvements.

Smart
Investigation Orchestration

Guided by AI, investigators navigate a structured, question-by-question journey tailored to their specific investigation needs. This intuitive approach breaks down complex scenarios into actionable steps, ensuring thoroughness without overwhelm.

Automated
Inventory Management

Utilize AI to automatically categorize and prioritize complaints based on severity, ensuring that critical issues are addressed promptly.

Intelligent
Content Optimization

Leverage AI-powered content review to ensure your investigations are aligned with regulatory language, well-structured, and grammatically accurate. This ensures all reports meet compliance standards and convey professionalism.

Comprehensive
Pattern Insights

Analyze investigation data across workflows to identify recurring patterns and systemic issues. By addressing root causes proactively, the platform helps prevent future deviations and enhances overall quality assurance.

Ready to Get Started?

300+ pharma facilities worldwide use Leucine to stay compliant. Talk to one of our expert consultants at Leucine to learn how.

Schedule Demo