Quality

Agatha QMS offers a cloud-based solution for managing quality documents and processes, specifically designed for CAPAs, deviations, and change controls. It ensures compliance with ER/ES guidelines and 21 CFR Part 11, providing secure document management, sharing, and digital original documentation. The system maintains operation logs and audit trails to ensure data integrity compliance, meeting GxP requirements and enhancing quality management in regulated industries.

Agatha QMS centralizes event management, linking deviation management, complaint handling, CAPA, and change control events for complete traceability. Reports and records are stored in the cloud, improving data visibility and connectivity. The system is GMP-compliant, supports 21 CFR Part 11 and DI requirements, and allows for quick retrieval of essential records during audits and inspections.

Progress tracking and trend analysis are streamlined with automatic database integration, eliminating manual reporting. An alert system ensures deadlines are met by notifying relevant personnel based on predefined triggers. Agatha QMS supports multiple languages, including Japanese and English, facilitating centralized event management across global operations and ensuring regulatory compliance worldwide.

Agatha QMS Benefits

• Regulatory Compliance: Ensures adherence to standards like 21 CFR Part 11, ISO 13485, GMP, and GCP, centralizing deviation management and CAPA.
• Increased Productivity: Workflow automation and systemization reduce manual tasks and errors, improving efficiency.
• Improved Risk Management: Real-time data analysis allows early issue detection and swift corrective actions, minimizing quality risks.
• Cost-Effective Implementation: Cloud-based operations reduce deployment and maintenance costs, eliminating the need for on-premise servers.
• Advanced Security: Secure cloud environment with granular access control ensures data integrity and confidentiality.

Main features include advanced forms, metrics and reporting, and complete records management. Users can work with standard forms or customize them as needed, with built-in reviews, approvals, and assignments to achieve quality objectives. Cross workspace reporting and export options to Excel are available, and QMS forms can be converted to PDF for signed electronic records, fully compliant with regulatory requirements.