QualiPilot: Auditor

QualiPilot: Auditor is an AI-powered compliance and auditing tool designed specifically for medical device manufacturers and quality management systems. It helps organizations maintain compliance with key regulatory standards including ISO 13485:2016 and FDA 21 CFR Part 820 (Quality System Regulation).

Key features include:

Clause-Aware Auditing: The system can analyze documentation against specific regulatory clauses, identifying non-conformities and providing evidence-based recommendations.

One-Click Audit Checklists: Users can generate comprehensive audit checklists tailored to specific topics like document control, CAPA, design controls, or production processes.

AI-Powered Compliance Analysis: The compliance analyzer can evaluate specific questions against regulatory requirements, providing verdicts with supporting citations.

Auditor Chat: An AI assistant that can answer questions about regulatory requirements and provide guidance on compliance issues.

CAPA Management: A Kanban-style interface for tracking Corrective and Preventive Actions, with the ability to assign owners, set due dates, and monitor progress.

Evidence Collection: Users can upload and manage evidence files for audit findings, maintaining a complete audit trail.

Workspace Collaboration: Team-based access control with different roles (Admin, Auditor, Auditee) for collaborative auditing.

Exportable Reports: Generate PDF and CSV reports for regulatory submissions and internal documentation.