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Configurable statistical alert rules using control charts, trending algorithms, and custom thresholds

Automated OOT alert generation when results show statistically significant trends toward specification limits

Investigation workflow to determine if the trend is a true process shift or analytical variability

Integration with LIMS for real-time data feed and historical trend visualization

Risk assessment of OOT findings with impact analysis on product quality and patient safety

Auto-escalation to deviation and CAPA if the OOT investigation confirms a process change

Dashboard showing trend trajectories across stability, in-process, and release testing parameters