Top 28 Vault eTMF Features to Drive Inspection Readiness

Although TMF management was once considered a back office function, TMF leaders are increasingly proving that it’s a strategic asset to their organizations. These leaders are using eTMF as the foundation for R&D transformation and, ultimately, simplifying inspections and getting products to market faster.

Here, I’ve highlighted 28 of my favorite capabilities that Vault eTMF delivers to our customers to enable their vision for TMF as a highly strategic function. They are listed in a hierarchy/taxonomy in honor of the TMF Reference Model. These are my top features:

Planning and study setup

1. Align your standard content structure/TMF index with the TMF Reference Model
2. Identify documents that need to be collected for a given study with templated milestones and Expected Documents Lists (EDLs)
3. Configure granular system access with Dynamic Access Control
4. Maintain a cross-study database of organizations and personnel with Global Directory
5. Drive the collection of product, organization, and person-specific content with EDL automation
6. Maintain the status of the trial with milestone automation

Content processing

7. Automate document metadata population by dragging and dropping content to an expected document
8. Reduce the risk of unintentional unblinding with pre-populated document blinding
9. File relevant email communications as documents by simply sending them to an inbound email address, driving compliance and efficiency
10. Process documents more quickly and increase TMF compliance with the TMF Bot for auto-classification and QC assistance
11. Support more efficient filing with the Promote to Approved (Direct to Final) workflow for relevant communications
12. Get real-time collaborative authoring on all clinical documents in a compliant way in Microsoft Office Online
13. Support document creation from a template with authoring workflows
14. Review workflows easily with annotations
15. Kick off QC review workflows that prompt for resolution of identified Quality Issues
16. Generate approval workflows with eSignature

TMF awareness and visibility

17. Get a high-level overview of TMF milestones and completeness with the TMF Homepage
18. Search and access all document versions, as well as export data to Microsoft Excel, with the TMF Viewer
19. Create personalized filters in the document library for easy viewing
20. View and analyze standard Timeliness, Completeness, and Quality reports to track TMF health
21. Configure reports to suit your organization’s needs
22. Schedule flash reports at any frequency for complete visibility

Inspection readiness

23. Allow TMF teams to request review by relevant business subject matter experts with multi-document workflows for post-approval QC
24. Filter documents that may still require review with the Inspection Ready flag for content
25. Identify trends and ensure issues are remediated with Quality Issues on pre- and post-approval QC
26. Grant auditors and inspectors views and access to simplify inspections

Connection and collaboration

27. Streamline TMF archival with a single-click archival initiation process
28. Enable study teams to quickly and accurately transfer TMF documents without manual end-of-study migrations with TMF Transfer

For more TMF management best practices, read part one in a series of checklists to create and maintain an inspection-ready culture and prepare for a regulatory inspection.