CLEEN

CLEEN is a cleaning validation software tool developed by Leucine, designed for pharmaceutical manufacturers that need to automate residue limit calculations, manage validation protocols, and maintain compliance with FDA and global regulatory standards. It targets quality and manufacturing teams responsible for ensuring that equipment cleaning processes meet regulatory expectations, including those set out in 21 CFR Part 11 and HBEL-based guidelines.

The software centralises cleaning validation workflows — from carryover limit analysis and worst-case scenario assessment to protocol generation and audit documentation — reducing reliance on manual processes and supporting faster decision-making across production lines.

Compliance and Regulatory Alignment

• Automates HBEL-based residue limit calculations to reduce human error and meet FDA and global regulatory standards.
• Fully complies with 21 CFR Part 11, providing secure audit trails, electronic signatures, and role-based access control.
• Automates risk evaluation for process and product changes to support compliant change impact assessments without disrupting production timelines.
• Generates audit-ready documentation aligned with FDA inspection expectations.

Residue Limit Calculation and Risk Assessment

• Evaluates all residue types and active pharmaceutical ingredients (APIs) using a rule-based calculation engine to define safe carryover limits.
• Supports new drug introduction risk assessments by calculating carryover limits, risk scores, and worst-case scenarios for introducing new drugs into existing production lines.
• Enables instant go/no-go decisions for manufacturing expansions through rapid, risk-based carryover limit calculations.

Protocol Generation and Execution

• Auto-generates standardised, compliant validation protocols by combining limit data, worst-case scenarios, and essential cleaning parameters, tailored to specific products and equipment.
• Streamlines cleaning validation protocol execution to reduce batch downtime and minimise interruptions during production.

Real-Time Validation Tracking and Reporting

• Provides a central dashboard for tracking validation status across equipment and processes in real time.
• Pulls residue results and key parameters from LIMS to generate coherent final validation summaries.
• Integrates residue data from LIMS to produce comprehensive validation reports.
• Includes an Audit Portal that allows users to retrieve historical validation data instantly and generate configurable reports to meet specific regulatory requirements.

System Integrations

• Integrates with LIMS, QMS, and ERP systems to eliminate manual data silos and support a connected validation ecosystem.

CLEEN is part of Leucine's broader MES Essentials suite, which also includes tools for batch execution, AI-assisted investigation writing, environmental monitoring, and FDA tracking. The platform is positioned for pharmaceutical manufacturers seeking to reduce compliance risk, accelerate audit readiness, and support new drug introductions within regulated manufacturing environments.