GxP Deviation Prediction

Challenge – High Deviation Rates and Delays
A leading pharma manufacturer faced recurring GxP batch deviations, with a 10% defect rate causing delays in product release and rising compliance costs. Root-cause investigations were slow, and quality teams lacked real-time visibility into deviation triggers across IoT, MES, and ERP systems.

Solution – Predictive Deviation Analytics Platform
NucleusTeq implemented a real-time predictive quality solution combining Nova (NuoData) and Spectra (NuoData). The platform ingested continuous IoT sensor data, production parameters, and ERP logs to detect anomalies proactively. ML models were trained to identify deviation probability, root causes, and preventive actions while maintaining data integrity under GxP and FDA guidelines.

Impact – From Reactive Quality Checks to Predictive Assurance
• 20% reduction in deviation rates
• 30% faster quality investigations
• $2M annual savings in compliance and rework costs

By embedding predictive intelligence within manufacturing workflows, the company achieved a more compliant, efficient, and proactive quality environment — setting a new benchmark for operational excellence in life sciences.