Agatha

Agatha is a cloud-based document management and process management platform for life sciences organizations. It supports biotech, pharmaceutical, medical device, CRO, and healthcare teams with centralized handling of clinical operations, quality management, regulatory submissions, and clinical trial documentation.

The platform includes applications for SOP management, regulatory document creation and storage, quality document and process management, remote investigator site file (ISF) management, and electronic trial master file (eTMF) workflows. It is designed to streamline document creation, sharing, review, approval, and storage while supporting paperless operations and controlled collaboration.

Agatha is built for organizations that need secure, compliant document management across global and domestic operations. It supports regulatory requirements such as FDA 21 CFR Part 11, GDPR, and EU Annex 11, making it suitable for teams that need structured workflows, audit-ready records, and consistent document control in regulated environments.

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