Agatha eTMF, QMS, Document Management Software for life sciences - Biotech - Medical device - Pharma

This video provides an overview of Agatha, an electronic document management (EDM) suite specifically designed for the highly regulated life sciences sector, including pharmaceutical, biotech, and medical device companies. The primary goal of the platform is to help these organizations scale operations, streamline processes, and accelerate the time-to-market for their products by establishing a centralized, compliant, and paperless document repository. The presentation details how Agatha moves beyond traditional or "legacy platforms" by offering a full-featured, cloud-based solution focused on ease of use and cost-effectiveness.

The core functionality of Agatha centers on controlling the entire document lifecycle, from initial drafting and review through distribution and final archiving, ensuring a "single source of truth" for all critical documentation. The suite is modular, offering specialized applications such as Agatha Clinical eTMF (Electronic Trial Master File), Agatha Remote ISF (Investigator Site File), Agatha SOP, Agatha Quality, and Agatha Regulatory. This specialization allows the platform to cater directly to the needs of clinical operations and quality management departments, which are central to regulatory success in the life sciences.

A critical component of Agatha’s value proposition is its robust regulatory compliance and guaranteed inspection readiness 365 days a year. The platform achieves this through comprehensive features like full traceability and detailed audit trails. Explicitly, Agatha applications are compliant with major global regulations, including FDA 21 CFR Part 11, GDPR, and EU Annex 11, which ensures secure and legally sound electronic signatures. Furthermore, the system is designed to embed quality systems into the business structure by allowing users to build customizable workflow and lifecycle templates. These templates automatically route necessary actions to the appropriate personnel at the correct time, facilitating proactive quality control. The platform also features tools to quickly view training statuses, enabling organizations to identify and address non-compliance issues efficiently. The overall approach is to provide a clean, user-friendly interface where personnel can easily complete tasks, search documentation, track metrics, and build reports from a central dashboard.

Key Takeaways: • Agatha is a dedicated electronic document management (EDM) suite tailored for the life sciences industry (Pharma, Biotech, Medical Device), focusing on streamlining clinical operations and quality management (QMS). • The platform functions as a centralized, paperless repository that manages the complete document lifecycle—from drafting and review to distribution and archiving—establishing a single source of truth for all critical documentation. • A key feature is the guarantee of inspection readiness year-round, which is supported by comprehensive audit trails and full traceability of all document actions and changes within the system. • Regulatory compliance is foundational, with the platform explicitly meeting the requirements of FDA 21 CFR Part 11, GDPR, and EU Annex 11, ensuring the validity and security of electronic signatures. • The suite includes specialized, modular applications addressing core industry needs, such as Agatha Clinical eTMF, Agatha Remote ISF, Agatha SOP, Agatha Quality, and Agatha Regulatory documentation management. • Quality processes are controlled and automated through the ability to build custom workflow and lifecycle templates, which ensure that required actions are routed to the correct personnel promptly. • The system aids in organizational compliance by allowing users to quickly view training statuses, making it easy to identify and address pockets of non-compliance across the business. • Agatha positions itself as a modern, lower-cost alternative to complex legacy platforms, emphasizing ease of implementation and a user-friendly interface to achieve tangible results faster. • Users interact with the platform via a clean dashboard interface, which facilitates task completion, documentation searching, metric tracking, and report generation. • The platform is designed to embed quality systems into all layers of the business, moving beyond simple storage to actively manage and enforce quality processes and documentation standards. • A testimonial from a Senior Quality Manager at NS Pharma highlights the platform’s simplicity and ease of use, noting that it was a reasonable cost investment compared to other complicated systems available to smaller biotech firms.

Tools/Resources Mentioned:

• Agatha Clinical eTMF
• Agatha Remote ISF
• Agatha SOP
• Agatha Quality
• Agatha Regulatory

Key Concepts:

• Electronic Document Management (EDM): A system for managing documents throughout their lifecycle, from creation to disposition, in an electronic format.
• eTMF (Electronic Trial Master File): A digital repository for the essential documents required to conduct a clinical trial, ensuring compliance and inspection readiness.
• 21 CFR Part 11: The FDA regulation governing electronic records and electronic signatures, ensuring they are trustworthy, reliable, and equivalent to paper records and handwritten signatures.
• EU Annex 11: The European regulation concerning computerized systems used in regulated GxP activities.
• Inspection Readiness: The state of having all necessary documentation, processes, and audit trails organized and accessible to satisfy regulatory inspections at any given time.