Agatha Quality

Agatha Quality (Agatha QMS) is a cloud-based Quality Management System developed by Agatha Corporation, designed for life sciences and other highly regulated industries. It provides comprehensive document and process management for CAPAs, deviations, change controls, and complaint handling, ensuring organizations meet stringent regulatory requirements including 21 CFR Part 11, ISO 13485, GMP, and GCP standards.

Agatha QMS is built for quality and compliance teams operating in global, multi-site environments who need centralized event management, seamless inspection readiness, and data-driven quality improvements — all without the overhead of on-premise infrastructure.

Compliance and Document Management

• Fully compliant with Electronic Records/Electronic Signatures (ER/ES) guidelines and 21 CFR Part 11, supporting secure digital original document management in the cloud.
• Records operation logs and audit trails to ensure Data Integrity (DI) compliance across all quality processes.
• Meets GxP requirements, enhancing quality management in highly regulated industries.
• QMS forms can be converted to PDF at any point, producing appropriately formatted, signed electronic records ready for inspection.

Centralized Event Management and Inspection Readiness

• Links deviation management, complaint handling, CAPA, and change control events to ensure complete traceability across the quality lifecycle.
• All reports and records are stored in the cloud, enhancing data visibility and connectivity.
• Supports GMP compliance and 21 CFR Part 11 and DI requirements, enabling quick and efficient retrieval of essential records during audits and inspections.
• Centralizes quality information to facilitate smooth audit responses and reduce operational burdens.

Main Features and Capabilities

• Advanced Forms: Work with ready-to-use standard forms and processes, or adapt them using a form designer to update the look and framework. A dynamic, multipart form supports all steps in a process from deviation to change control, adding appropriate sections based on information provided at each stage.
• Built-in Reviews and Approvals: Reviews, approvals, and assignments for actions are built into the workflow to help businesses reach their quality objectives.
• Metrics and Reporting: Built-in dashboards and reports provide all necessary reporting. Custom reports can be generated and exported to Excel or CSV format. Cross-workspace reporting allows views and reports to be created across workspaces and exported to Excel for dashboard reports.
• Complete Records: Full quality records with signatures and audit trails are maintained and ready for inspection, fully compliant with 21 CFR Part 11 and EU regulatory requirements.
• Forms and PDF Export: QMS forms can be converted to PDF at any point, resulting in a properly formatted, signed electronic record.

Workflow Automation and Progress Tracking

• Automatic database integration stores all event records in the cloud, eliminating the need for manual progress tracking and trend analysis reports.
• An alert system ensures deadlines are met by automatically notifying and reminding relevant personnel based on predefined triggers.
• Version control, access management, and workflow automation reduce manual tasks, prevent errors, and standardize quality management operations across the organization.

Key Benefits

• Regulatory Compliance: Ensures adherence to 21 CFR Part 11, ISO 13485, GMP, and GCP, with centralized management of deviations, change controls, CAPA, and quality information.
• Increased Productivity: Systemization and workflow automation reduce manual effort and standardize quality operations organization-wide.
• Improved Risk Management: Real-time quality data analysis enables early detection of potential issues and swift corrective actions, minimizing quality risks.
• Cost-Effective Implementation: Eliminates on-premise server management costs and reduces printing and storage expenses through paperless operations.
• Advanced Security: Operates in a secure cloud environment with granular permission settings, ensuring authorized personnel access only the information they need to safeguard data integrity and confidentiality.

Global and Multi-Language Support

• Supports multiple languages including Japanese and English, enabling centralized event management across global locations.
• Meets 21 CFR Part 11 and DI compliance standards worldwide, with multilingual customer support available to facilitate seamless international business operations.

Agatha QMS is deployed as a cloud-based solution, removing the need for on-premise server infrastructure. It is suitable for pharmaceutical, medical device, and other life sciences organizations seeking to streamline quality management, reduce compliance risk, and improve inspection readiness on a global scale.