QuantumQS Information

QuantumQS bridges the gap between regulatory quality systems and AI/ML integration. As AI and machine learning are introduced into GxP impacting processes, including quality systems, manufacturing, document control, data analysis, and decision support, the underlying tools need to be validated, not just functional. QuantumQS helps medical device, pharma, and biotech companies validate AI/ML systems inside regulated environments. Applicable regulatory frameworks include FDA QSR and QMSR, ISO 13485, EU MDR, cGMP, the EMA's revised Annex 11 on computerized systems, the new Annex 22 on artificial intelligence, and the EU AI Act where relevant.