QMS for Clinical and Compliance. Complete.

Agatha Quality

A complete, closed-loop system for documenting Deviations, tracking Corrective Actions (CAPAs), managing Audits and coordinating Change Control activities.

Agatha Quality is a complete, ready-to-use application for capturing deviations, documenting corrective and preventive actions (CAPAs), and managing change control processes. 

Finally, a Quality Solution Designed for Clinical and Compliance Professionals

Effectively managing clinical, compliance and quality processes is a mission critical task at life sciences companies. Quality improvements accelerate trials and improve results, while quality failures can result in huge costs and disruptions. Choosing the right solution to track quality processes in clinical trials is a critical decision.   

More than document management, Agatha Quality is an end-to-end quality management system. Combining forms, documents and workflows, Agatha Quality comprises a complete toolset for quality managers, pre-configured, validated, and ready-to-use but easy to adapt to specific process requirements.

Benefits

End-to-End

Complete, closed-loop process captured in an expanding form, from initial issue to preventative action.

Complete QMS

Captures deviations, CAPAs, change controls, and audit activities to cover every part of the quality process.

Inspection-Ready

Creates complete quality records with electronic signatures, recorded approvals and audit trails, all ready for inspection.

Fully Compliant 

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.

Arun Bhatt

Quality of Clinical Trials: A Moving Target, Perspect Clin Res. 2011 Oct-Dec; 2(4): 124–128.

Agatha Quality Features

Closed-Loop

All process steps on one, multi-part form from deviation to change control

Ready to Use

Ready-to-use with standard forms and processes, but easy to adapt 

COMPLete Records

Complete quality records with signatures and audit trails, ready for inspection

metrics and reports

Dashboards, reports and exports to support reporting needs

Compliant and Validated

 Compliant with 21 CFR Part 11 and EU regulatory requirements

automated actions

Reviews, approvals and assignments for actions built-in

Agatha Applications

Agatha Clinical

Inspection-ready Management of Essential TMF Documents and Records

Agatha SOP

Creation, Review and Approval of SOPs and Employee Training Records

Agatha Quality

Quality Document and Process Management for CAPAs, Deviations, & Change Control

Agatha Regulatory

Easily manage your regulatory documentation following the EDM Reference Model.

Ready to learn more about Agatha's Applications? Maybe it's time to think about a trial.

But not just any trial - an Agatha trial.

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Agatha offers a fully supported free pilot where you can test our applications using your real information and processes.

Just fill in the form arrow pointing to a form
and we’ll get right back to you to get you set up.

If you're not sure, you can learn more about our Pilot process here. If you’re not quite ready to sign up for the pilot, request a demo instead.

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