Transform temperature validation from reactive documentation to proactive risk prevention. TRAXX Stability Monitoring uses its TRAXX AI-powered analytics to continuously assess temperature performance across your critical assets, ensuring regulatory compliance while preventing costly product losses before they occur.
Prevent Product Loss Before It Happens
TRAXX AI detects micro-variations and environmental risks that traditional monitoring systems miss, protecting research investments and ensuring regulatory compliance.
Real-Time Stability Scoring with 21 CFR Part 11 Compliance
TRAXX AI analyzes temperature patterns across your entire cold storage fleet to predict stability risks days or weeks before traditional alarms trigger. Every measurement, alert, and validation report maintains full audit trails and electronic signature capabilities required for FDA inspections.
AI-Powered Pattern Recognition Beyond Standard Monitoring
While traditional systems only alert when temperatures breach thresholds, TRAXX AI detects subtle pattern changes—like compressor stress, door seal degradation, or HVAC interference—that indicate impending stability failures. Our machine learning models, trained on 100+ billion sensor readings, identify risks that human analysis and conventional monitoring miss entirely.
FDA VALIDATION READY
Complete IQ/OQ/PQ Documentation
TRAXX provides comprehensive validation support through Installation Qualification (IQ) and Operational Qualification (OQ) protocols that guide customers through FDA-compliant deployment. Our IQ documentation ensures proper software installation and configuration, while OQ protocols verify operational performance across all specified ranges and data fields.
KLATU offers consulting services to help customers execute IOQ testing that simulates real-world conditions, providing the documentary evidence required before regulated deployment while preserving the predictive analytics that set TRAXX apart from traditional monitoring systems.
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