CLEEN

CLEEN is a comprehensive cleaning validation software designed to streamline FDA compliance processes. It automates the analysis of safe carryover limits and monitors residue trends in real-time, ensuring that cleaning protocols meet worst-case product scenarios. The software generates audit-ready documentation, facilitating seamless alignment with FDA standards.

Key features include automated risk evaluation for process and product changes, which helps maintain compliance while minimizing production disruptions. CLEEN performs HBEL-based residue calculations to eliminate manual errors, ensuring adherence to FDA and global regulatory standards. It also accelerates new drug introduction by providing instant risk-based assessments and rapid carryover limit calculations, aiding in quick go/no-go decisions for manufacturing expansions.

The software offers real-time validation tracking across equipment and processes from a central dashboard, enabling faster audits and proactive decision-making. It streamlines cleaning validation protocols, reduces batch downtime, and optimizes productivity by minimizing interruptions during protocol execution.

Features and Benefits:

• Accurate HBEL-based residue limit calculations using a rule-based engine to reduce human error.
• Instant assessment of new drug introduction risks, including carryover limits and worst-case scenarios.
• Auto-generation of standardized, compliant protocols tailored to specific products and equipment.
• Seamless integration with LIMS for comprehensive validation reports and real-time status tracking.
• Audit portal for instant retrieval of historical validation data and configurable report generation.

CLEEN integrates with LIMS, QMS, and ERP systems, eliminating manual data silos and providing a connected validation ecosystem. It supports HBEL-based cleaning validation protocols and complies with 21 CFR Part 11 for data integrity, offering secure audit trails, electronic signatures, and role-based access control.