Arex: GxP-Compliant FDA SOP AI Compliance Agent

Arex is a state-of-the-art GxP-compliant compliance agent and document remediation workspace designed to automate complex regulatory gap analyses for life sciences, healthcare, and medical device organizations. Operating under rigid FDA 21 CFR Part 11 requirements, Arex parses newly issued regulatory updates and compares them semantically against a company's internal library of Standard Operating Procedures (SOPs). By utilizing a LangGraph multi-agent state machine and a Qdrant vector database scoped for multi-tenant isolation, Arex identifies compliance gaps, calculates risks, and produces color-coded PDF highlights or native DOCX revisions without altering file structures. Approved changes generate immutable audit trails, electronic signatures, and department-specific implementation tasks pushed directly to Atlassian Jira Cloud. In Hackathon Mode, Arex leverages open-source models served on AMD Instinct™ GPUs via Fireworks AI for hardware-accelerated, high-performance inferences, ensuring speed, security, and audit readiness.