How to build a Quality Control and Regulation (CAPA) Agent

This workflow streamlines the creation of Corrective and Preventive Action (CAPA) reports for regulated industries. Users submit structured incident details—such as product or process affected, date, severity, and how the issue was detected—along with optional supporting evidence like complaint forms, batch records, or lab reports.

The AI then analyzes the incident information and uploaded files, searches a connected knowledge base containing past CAPA reports, SOPs, and templates, and drafts a comprehensive CAPA document. The report follows a standard regulatory structure: Problem Statement, Scope and Impact Assessment, Immediate Containment Actions, Root Cause Analysis, Corrective Actions, Preventive Actions, Effectiveness Check, and References.

A built-in severity router evaluates the drafted report. If the incident is flagged as critical or major, the workflow automatically sends an email notification to the QA or Quality Lead, ensuring urgent issues receive immediate attention. For all incidents, the final CAPA draft is displayed for review, editing, and export into the organization's Quality Management System.

This agent reduces documentation time, ensures consistency with past practices, and helps maintain audit-ready compliance—all while keeping the right people informed when it matters most.