BatchCortex provides AI-powered batch monitoring for pharmaceutical manufacturers, helping quality teams detect production deviations early and reduce the risk of failed batches. Its platform analyzes live equipment and process data, identifies emerging anomalies, and brings relevant sensor readings, model outputs, and operator context together for investigation. Features include real-time alerts, automated escalation, and AI-generated deviation reports, batch-record annotations, and CAPA drafts prepared for quality review and Qualified Person signature.

Designed for regulated manufacturing, BatchCortex supports GMP Annex 11 requirements and readiness for the evolving Annex 22 framework. Its audit records capture model confidence, thresholds, operator actions, machine states, and other batch evidence, with traceable signatures and inspection-ready exports. The platform connects in read-only mode to existing systems through OPC-UA and MQTT, without requiring changes to production equipment. BatchCortex also offers an interactive demonstration, a browser-based pack verification tool, pilot applications, and tiered pricing. Its stated goal is to help manufacturers reduce waste, investigation workload, and release delays, ultimately lowering production costs.