QMS for Clinical and Compliance. Complete.
A Quality Solution Designed for Clinical and Compliance Professionals
Every industry has unique quality management requirements. And this isn’t a manufacturing industry.
Agatha Quality (QMS)
Agatha Quality (QMS) is a complete, ready-to-use quality management application for capturing deviations, documenting corrective and preventive actions (CAPAs), and managing change control processes.
Most vendors provide quality management forms that are targeted towards manufacturing, but Agatha QMS is focused on the key forms needed to audit Clinical Processes (audit of Sites, CROs, etc.)
More than document management, QMS is an end-to-end quality management system. Combining forms, documents, and workflows, Agatha QMS comprises a complete toolset for quality managers, pre-configured, validated, and ready-to-use but easy to adapt to specific process requirements.
With Agatha Quality, you get…
An End-to-End Process
A complete, closed-loop process captured in an expanding form, from initial issue to preventative action.
A Complete QMS
Capture deviations, CAPAs, change controls, and audit activities to cover every part of the quality process.
Create complete quality records with electronic signatures, recorded approvals, and audit trails, all ready for inspection.
A validated system that is compliant with GxP requirements, EU Regulations, and FDA 21 CFR Part 11.
Compliance to quality requirements is the cornerstone of a scientifically valid and ethically sound clinical trial. The twin objectives of quality — data integrity and subject projection — can be met by a systematic approach to the whole process of a conduct of clinical trials.
What you get with Agatha QMS
Complete Metrics and Reporting
Get all the reporting you need with built-in dashboards and reports, and export reports for external reporting requirements.
Cross Workspace Reporting: You can also create views and reports across workspaces and export results to Excel for dashboard reports.
Work with ready-to-use standard forms and processes, or adapt them to support your needs. Forms include rich text fields that allow the addition of images and formatted text. Use the form designer to update the look and feel of your forms.
A single multi-part form supports all steps in a process from deviation to change control. Reviews, approvals, and assignments for actions are also built-in.
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.
Agatha’s quality management application is also fully integrated with other Agatha applications making it easy to create references between them (eg. A CAPA can reference an SOP).
More Than an Online Record
QMS forms are built on a Word template. When the form is converted to PDF, it’s more than a simple screenshot of the form on the page. Instead, you get a signed electronic record that is a nicely formated PDF.
You Get More With Agatha Quality (QMS)
Basic Preview and Annotations
Advanced Integration Toolkit
Use Agatha’s Rest API to allow applications to upload or export items from Agatha (includes documentation & sample code).
Advanced Policy and Access Management
Get the Edition of Quality Management That Works for You
- Pre-validated functionality for core ClinOps processes
- Check-in, Check-out, and Version Control
- Electronic Signatures and Complete Audit Trails
- Flexible review and approval workflows
- Full compliance with 21 CFR Part 11 and related Regulations
- All Standard Features, Plus
- Advanced reporting with Metrics and Dashboards
- Live Co-annotation for simultaneous review of documents
- Custom forms capability
- Advanced, role-based access management
- Everything in Extended
- “In Application” Microsoft Word and Excel editing – No Word required
- Live collaborative authoring and editing
- Extended template sets for SOPs, Informed Consent, and more
- Integration toolkit with Rest API support
The best way to know if an Agatha Application meets your needs is to try it out. And good news - we offer a free trial.
Complete the form, select the application you would like to try and we'll reach out to get you set up as quickly as possible.
Want a little more information on your trial process? Go here.