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Quality Document and Process Management for CAPAs, Deviations and Change Controls

How we help

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Ensure Compliance and Digital Original Document Management in the Cloud

Agatha QMS is a cloud-based solution compliant with ER/ES guidelines and 21 CFR Part 11, enabling secure document management, sharing, and digital original documentation. It also records operation logs and audit trails, ensuring data integrity (DI) compliance. By meeting GxP requirements, Agatha QMS enhances quality management in highly regulated industries.

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Centralized Event Management for Seamless Inspection Readiness

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

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Streamlined Progress Tracking, Trend Analysis, and Delay Prevention with Alerts

With automatic database integration, all event records are stored in the cloud, eliminating the need for manual progress tracking and trend analysis reports. The alert system ensures that deadlines are met by automatically notifying and reminding the relevant personnel based on predefined triggers.

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Global Multi-Language Support for International Operations

Agatha QMS supports multiple languages, including Japanese and English, enabling centralized event management across global locations. It meets 21 CFR Part 11 and DI compliance standards, ensuring regulatory adherence worldwide. Additionally, multilingual customer support is available, facilitating seamless global business operations.

Agatha QMS Benefits

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    Regulatory Compliance and Streamlined Inspection Readiness
    Agatha ensures compliance with regulatory standards such as 21 CFR Part 11, ISO 13485, GMP, and GCP, while centralizing deviation management, change control, quality information, and CAPA (Corrective and Preventive Actions). This facilitates smooth audit responses and reduces operational burdens.
  • Agatha Regulatory Benefits
    Increased Productivity Through Systemization and Workflow Automation
    With version control, access management, and workflow automation, Agatha reduces manual tasks, prevents errors, and standardizes quality management operations, improving efficiency across the organization.
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    Improved Risk Management and Data-Driven Quality Enhancements
    Real-time quality data analysis enables early detection of potential issues, allowing for swift corrective actions. By optimizing deviation management, CAPA, and change control processes, Agatha minimizes quality risks and enhances overall compliance.
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    Cost-Effective Implementation with Reduced Time and Effort
    By eliminating the need for on-premise server management, Agatha reduces deployment and maintenance costs. Additionally, paperless operations lower printing and storage expenses, making quality management more cost-efficient.
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    Advanced Security and Flexible Access Control
    Operating in a secure cloud environment, Agatha ensures that the latest security measures are always in place. Granular permission settings allow authorized personnel to access only the necessary information, safeguarding data integrity and confidentiality.
NS Pharma improves its Quality and eTMF management with Agatha
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Main Features

Work with ready-to-use standard forms and processes, or adapt them to support your needs. Use the form designer to update the look and framework of your forms. 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. Reviews, approvals, and assignments for actions are also built-in to help businesses reach their quality objectives.
Get all the reporting you need with built-in dashboards and reports, generate custom reports and export any report to Excel or a generic CSV format. Cross Workspace Reporting: You can also create views and reports across workspaces and export results to Excel for dashboard reports.
Get complete quality records with signatures and audit trails, ready for inspection. Agatha QMS is fully compliant with 21 CFR Part 11 and EU regulatory requirements.
QMS Complaint - Preview of a complaint converted to PDF based on word template
QMS forms in Agatha can be converted to PDF at any point, resulting in an appropriately-format, signed electronic record.

Ready do dive in?

For inquiries about our products and services, or to sign up for a demo, click here.