Product Overview
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 during a clinical research project. Most vendors provide quality management forms that are targeted towards “widget” manufacturing, but Agatha QMS is focused on the key forms needed for ClinOps and life sciences GMP environments.
Effectively managing clinical, compliance, and quality processes and protocols is a mission-critical task at life sciences companies. Quality improvements accelerate trials and improve the results of clinical studies, while quality failures can result in huge delays, added costs and major disruptions. Choosing the right solution for monitoring and managing quality processes in clinical trials and pharmaceutical manufacturing is a critical decision. It’s time to look at Agatha Quality as the foundation of quality for your ClinOps and GMP program..
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 during a clinical research project. Most vendors provide quality management forms that are targeted towards “widget” manufacturing, but Agatha QMS is focused on the key forms needed for ClinOps and life sciences GMP environments.
Risk-based monitoring and quality system: More than document management, QMS is an end-to-end quality management system. Combining forms, framework, documents, and workflows, Agatha QMS comprises a complete toolset for quality managers, preconfigured, validated, and ready-to-use but easy to adapt to specific process requirements.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
You Get More with Agatha Quality
Basic Preview and Annotations: Preview and annotate PDF and Office documents, and images in Agatha Quality’s report form.
Advanced Integration Toolkit: Use Agatha’s Rest API to allow applications to upload or export items from Agatha (includes documentation and sample code).
Cross Workspace Reporting: Create views and reports across workspaces and export results to Excel for dashboard reporting.
An End-to-End Process: A complete, closed-loop process captured in an expanding form, from initial issue to preventative action.
Inspection Ready: Create complete quality records with electronic signatures, recorded approvals, and audit trails, all ready for inspection.
Full Compliance: A validated system that is compliant with GxP requirements, EU regulations, and FDA 21 CFR Part 11.
About the company
Virtually all clinical and compliance solutions are based on traditional document management approaches. You know, check-in, check-out, yada yada. Agatha breaks the mold with better technologies to deliver a solution to manage end-to-end processes, not just documents. Agatha’s founders, saw firsthand that clinical and compliance solutions available in the market are built on excessively complex platforms and took far too long to bring to productive use. Lead times for implementing these unwieldy and costly systems are often as long as six months.
Clinical trials and compliance processes are the bridge between developing new drugs, devices, and therapies and getting them to the patients who desperately need them. Every day managing trials and compliance activities mean another day before a new drug or treatment is available to patients.
They set out to prove that a new class of cloud-first, ready-to-use applications could shorten the time required to get critical new drugs and treatments to patients.
