Zelthy Compliance is an AI-powered compliance monitoring and quality management platform for pharmaceutical field operations and regulated processes. It covers regulatory compliance workflows, audit trail management, standard operating procedures (SOP) and document control, corrective and preventive action (CAPA) management, pharmacovigilance support, adverse event capture and tracking, and quality event management. A key differentiating capability is system-driven integrity reporting — AI-powered monitoring of field team behaviour that flags anomalous data access patterns, auto-generates compliance logs, and surfaces potential integrity issues for review without requiring manual reporting from field staff. Key features and functionalities Zelthy Compliance deploys four AI agents that make compliance continuous rather than periodic: - an Integrity Monitoring Agent that tracks when and how field teams access patient and commercial data, identifies anomalous patterns, and auto-generates system-driven integrity reports; - an Adverse Event Signal Agent that analyses patient interaction data across PSP programs to detect pharmacovigilance-relevant signals requiring escalation; - a Quality Event Classification Agent that automatically categorises incoming quality events — deviations, complaints, CAPAs, by severity and routes them to the right quality team with suggested resolution pathways; - and an Audit Readiness Agent that continuously scores inspection readiness across all quality documentation, flags gaps, and generates pre-inspection action checklists. The platform is GxP-validated and fully compliant with 21 CFR Part 11 and EU Annex 11. All AI outputs carry an immutable audit trail and are validated for use in regulatory submissions and inspection responses. Primary value and solution provided Pharmaceutical compliance programmes fail in two distinct ways: either they catch violations too late — after an audit finding or a regulatory warning letter, or they generate so much compliance overhead that quality teams spend more time on documentation than on actual quality management. Zelthy Compliance addresses both failure modes. The AI integrity monitoring capability shifts compliance from reactive to real-time, catching field team anomalies and quality deviations as they happen rather than weeks later during a review cycle. The quality event classification and audit readiness agents reduce the administrative burden on quality teams by automating the triage and routing work that typically consumes the most time. The result is a compliance programme that is both more robust and less resource-intensive than the manual QMS approaches it replaces.