Vault Submissions Demo

This video provides an in-depth demonstration of Veeva Vault Submissions, a component of the Vault RIM suite, designed to streamline and manage the complex process of regulatory submissions to health authorities. The presenter frames Vault RIM as a single source of truth for planning, executing, and tracking all upcoming submissions. The demonstration highlights how the platform offers real-time project management capabilities, allowing users to visualize submission timelines, product associations, and team capacity, thereby facilitating better resource allocation and deadline management within pharmaceutical and life sciences organizations.

The core of the demonstration revolves around the submission content plan, which serves as a central hub for managing submission deliverables and document management tasks. A key feature discussed is the ability to leverage a global content plan or core dossier to efficiently reuse common documents across various markets. This approach significantly reduces duplication of effort when preparing local submissions, requiring only the addition and approval of market-specific documents. The content plan also functions as a project management tool, enabling filtering by deliverable owner and due dates, ensuring clear accountability and task management for individual team members.

The video further illustrates the collaborative authoring capabilities within Vault Submissions, demonstrating how multiple team members can simultaneously work on a document, with real-time visibility into each other's edits, preventing content conflicts. Once authoring is complete, documents are saved back to the Office 365 cloud and then to Veeva Vault. The platform offers comprehensive dashboards to track the status of all documents within a submission, broken down by module, owner, and completeness, providing a "one-stop shop" for monitoring progress. To expedite the approval process, the system supports multi-document workflows, allowing users to send entire modules or specific documents for electronic signature and approval, with statuses immediately reflected in the dashboard once completed, signaling readiness for dispatch to health authorities.

Key Takeaways:

• Centralized Submission Management: Veeva Vault RIM acts as a single, authoritative source for all regulatory submission activities, from initial planning to final dispatch, ensuring consistency and control across the entire lifecycle.
• Real-time Project Visibility: The platform offers dynamic dashboards that provide real-time data on upcoming submissions, including timelines, product associations, and team capacity, enabling proactive resource planning and deadline management.
• Global Content Reuse Strategy: Utilizing a global content plan or core dossier allows for efficient reuse of common documents across multiple markets, significantly reducing the effort and time required to prepare localized submissions.
• Integrated Document Management: The submission content plan not only defines the submission outline but also facilitates comprehensive document management, including authoring, review, and approval workflows within a secure cloud environment.
• Collaborative Authoring: Vault Submissions supports simultaneous collaborative authoring of documents, allowing multiple team members to work on the same content concurrently with real-time visibility, enhancing efficiency and reducing version control issues.
• Streamlined Approval Workflows: The system incorporates multi-document workflows, enabling the efficient routing of entire modules or individual documents for electronic signature and approval, accelerating the review process.
• Comprehensive Status Tracking: Dashboards provide an immediate overview of the status of all documents within a submission, categorized by module, deliverable owner, and completeness, offering a transparent and efficient way to monitor progress.
• Regulatory Compliance Support: The entire process, from document creation to electronic signatures and dispatch to health authorities, is designed to support regulatory compliance by providing a structured, auditable, and secure environment.
• Enhanced Team Efficiency: By centralizing information, automating workflows, and enabling collaboration, the platform significantly improves the efficiency of teams responsible for regulatory submissions, helping them meet critical deadlines.
• Data-Driven Decision Making: The availability of real-time data and comprehensive dashboards empowers project managers to make informed decisions regarding submission readiness and resource allocation.

Tools/Resources Mentioned:

• Veeva Vault RIM Suite (specifically Vault Submissions)
• Office 365 Cloud (for collaborative authoring and saving documents)

Key Concepts:

• Vault RIM: A suite of applications by Veeva Systems designed to manage regulatory information, including submissions, registrations, and quality processes, within the life sciences industry.
• Submission Content Plan: A structured outline within Vault Submissions that defines the required documents and their organization for a regulatory submission.
• Global Content Plan/Core Dossier: A strategy within Vault Submissions to create and manage a set of core documents that can be reused across multiple regional submissions, promoting efficiency and consistency.
• Multi-document Workflow: An automated process within Vault Submissions that allows for the simultaneous routing and approval of multiple documents, often requiring electronic signatures.
• Electronic Signature: A method for signing documents digitally, often with user credentials and capacity, to provide a legally binding approval, compliant with regulations like 21 CFR Part 11.