AI RESEARCH
GMPilot: An Expert AI Agent For FDA cGMP Compliance
arXiv CS.AI
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ArXi:2603.20815v1 Announce Type: new The pharmaceutical industry is facing challenges with quality management such as high costs of compliance, slow responses and disjointed knowledge. This paper presents GMPilot, a domain-specific AI agent that is designed to FDA cGMP compliance. GMPilot is based on a curated knowledge base of regulations and historical inspection observations and uses Retrieval-Augmented Generation (RAG) and Reasoning-Acting (ReAct) frameworks to provide real-time and traceable decision to the quality professionals.