Vault Submissions Archive Demo

This video provides an in-depth demonstration of Veeva Vault Submissions Archive, a component of the Vault RIM (Regulatory Information Management) Suite, designed to serve as a validated, centralized, cloud-based repository for accessing the complete history of regulatory submissions and health authority interactions globally. The core purpose of the application is to enable faster, more accurate interactions with health authorities by providing a single source of truth for all published outputs, including eCTD and non-eCTD formats (such as NCE, eAEU, and paper submissions). The presenter, a solution consultant, emphasizes the application's global capabilities, requiring no local software installation, and its adherence to stringent regulatory standards, specifically 21 CFR Part 11 and EU GMP Annex 11 requirements.

The demonstration focuses heavily on the user experience for navigating and retrieving specific regulatory content. The starting point is the Dossier Viewer, where users can select a specific application (e.g., an annual DCP application) and then refine the view using powerful filtering capabilities. Users can filter by sequence number, status, submission type, and actual submission date. A key feature highlighted is the advanced filtering, which allows users to search across metadata associated with the documents. For instance, the consultant demonstrates finding all sequences and associated documents where a specific manufacturer (Veeva from Brussels) has been published, quickly identifying the relevant sequences (5 and 6). Once a sequence is selected, users can visualize all associated documents, view lifecycle information, and open the actual document within the built-in viewer.

The true value proposition of Vault Submissions Archive, as articulated in the demo, lies in the connection between documents and data on the same platform. The built-in viewer not only displays the document content but also provides the associated metadata on the right side and the table of contents on the left, allowing for seamless navigation without returning to the main navigator. Furthermore, users can directly open the application record from the document view to see detailed background information. This integrated approach allows the platform to be used not just for archiving, but also for the planning and tracking of regulatory objectives and submissions, enabling users to manage dates and statuses effectively.

Finally, the demonstration concludes by showcasing the powerful reporting and dashboard capabilities inherent in the Vault platform. Vault Submissions Archive allows users to report on any data or documents stored within the system. A specific example, the "Application Chronology" dashboard, is presented as a valuable tool. This dashboard visually tracks the chronological progression of an application over time, including submitted and planned sequences, approved or pending regulatory objectives, and all health authority interactions, such as commitments and correspondence. This comprehensive view ensures that the archive functions as an authoritative source for submissions, correspondence, and regulatory planning.

Key Takeaways: • Centralized Global Repository: Vault Submissions Archive provides a single, cloud-based repository for all regulatory filings and health authority interactions worldwide, eliminating the need for local software and facilitating global sharing of submission history across the organization. • Comprehensive Format Support: The platform supports both eCTD (electronic Common Technical Document) and various non-eCTD electronic formats (NCE, eAEU) and even paper submissions, ensuring a complete historical record regardless of the original submission type. • Regulatory Compliance Assurance: The application is built to comply strictly with critical regulatory requirements, specifically 21 CFR Part 11 (governing electronic records and signatures in the US) and EU GMP Annex 11, ensuring the validated environment necessary for life sciences operations. • Advanced Search and Filtering: Users can quickly locate specific content using powerful search capabilities combined with filters based on status, submission type, date, and sequence, including advanced filtering that queries document metadata (e.g., searching by manufacturer name). • Integrated Dossier Viewer: A built-in viewer allows users to navigate the dossier easily in current, sequential, or cumulative views, providing immediate access to the content, associated metadata, and the table of contents simultaneously. • Connected Data Model: The platform connects documents and underlying data (metadata) on the same platform, allowing users to seamlessly transition from viewing a document to accessing the detailed record of the associated application for context and planning. • Regulatory Planning and Tracking: Beyond archiving, the system serves as a tool for managing regulatory objectives, allowing teams to track submission dates, statuses, and commitments directly within the same environment where the submission history resides. • Actionable Business Intelligence: The platform includes robust reporting capabilities, exemplified by the "Application Chronology" dashboard, which provides a chronological, visual representation of application progress, submitted sequences, regulatory objective approvals, and health authority correspondence. • Dynamic Access Control: Published outputs are stored securely with dynamic access controls, ensuring that only personnel with the appropriate permissions can view specific content, maintaining data integrity and confidentiality. • Streamlined Health Authority Interactions: By providing an authoritative, easily searchable source for all submissions and correspondence, the archive enables faster and more accurate responses and interactions with regulatory bodies globally.

Tools/Resources Mentioned:

• Veeva Vault Submissions Archive
• Veeva Vault RIM Suite
• eCTD (electronic Common Technical Document)

Key Concepts:

• 21 CFR Part 11: US FDA regulation governing electronic records and electronic signatures, ensuring their trustworthiness and reliability. Vault Submissions Archive is explicitly compliant with this standard.
• EU GMP Annex 11: European Union guideline concerning computerized systems used in regulated GxP environments. The platform ensures compliance with this standard.
• Dossier Viewer: The primary interface within the application used to view and navigate the complete set of published outputs (dossiers) for a specific application.
• Application Chronology: A specific business intelligence dashboard that visually tracks the timeline of an application, including sequences submitted, regulatory objectives, and health authority interactions.
• Health Authority Interactions: Refers to all formal communications, commitments, and correspondence exchanged between the pharmaceutical company and regulatory bodies like the FDA or EMA.