

Objective and Business Problem
The Johnson & Johnson Agentic Inspection Copilot System addresses the critical challenge of clinical trial inspection readiness in a dynamic, highly regulated environment. By automating a wide range of inspection activities, the system enhances efficiency, ensures compliance, and reduces manual effort and bias. This robust, scalable solution streamlines inspection processes, proactively identifies audit risks, and elevates real-time inspection readiness across thousands of sites globally, with an estimated financial benefit of approximately $1.5M projected at the PoC (Proof-of-Concept) stage.
Technical Content
The Copilot System employs a GenAI (Generative Artificial Intelligence) multi-agent workflow orchestrated by LangGraph to streamline inspection readiness. Multi-agents handle key functionalities such as autonomous Self-Retrieval-Augmented Generation (Self-RAG), OpenAI-powered LLM (Large Language Model) responses, and critique-refinement loops, ensuring precision and scalability. By dynamically processing sub-activities, integrating real-time feedback, and generating compliance-ready reports, the system delivers a concise, scalable solution for clinical trial inspection readiness.