Vault Submissions Publishing Demo

This video provides an in-depth demonstration of Veeva Vault Submissions Publishing, an end-to-end solution designed to manage the complex process of preparing, publishing, and submitting electronic regulatory content to global health authorities. The presentation highlights how the system streamlines content planning, publishing, and finalization, ensuring compliance with evolving regulations and optimizing the submission lifecycle for marketed products. It showcases preconfigured user and system actions that support a seamless workflow, from initial content planning to direct submission and acknowledgment tracking.

The demonstration begins with the creation of an application and foundational submission records within Vault Submissions, allowing users to specify critical information such as product families, submission types, and planned submission dates. A key feature is the ability to track health authority questions, ensuring ongoing engagement and compliance. The system then guides users through generating a comprehensive content plan using pre-loaded templates, which dynamically populates the submission record with all necessary modules and sections. This content plan can be customized by activating or deactivating specific modules (e.g., Module 5) based on the unique requirements of each submission, providing flexibility and control over the submission outline.

A core aspect of the system's efficiency is its "continuous publishing" and "continuous validation" capabilities. Continuous publishing automatically processes documents as they are associated with the content plan or updated, ensuring that the submission content is always current and ready. Furthermore, the system facilitates the creation of cross-document link annotations, converting internal hyperlinks into standard relative PDF links essential for regulatory submissions. Continuous validation is performed in real-time against health authority criteria (such as eCTD standards), immediately flagging errors or warnings (e.g., a missing submission contact) and allowing for their prompt resolution. The demo concludes by illustrating the final steps: locking documents, changing the content plan state to "complete," reviewing the assembled submission in the Submissions Archive Viewer, and finally, submitting directly to health authorities via a secure Gateway, with automatic tracking of acknowledgments.

Key Takeaways:

• Veeva Vault Submissions Publishing offers an end-to-end solution for managing the entire lifecycle of electronic regulatory submissions, from initial content planning and document assembly to final submission to health authorities.
• The system facilitates the creation of detailed submission applications and records, enabling users to specify product families, submission types (based on region and application), and planned submission dates, which helps prioritize publishing jobs.
• Content plans are dynamically generated using pre-configured templates and dossier formats, providing a comprehensive outline of the submission and allowing for the activation or deactivation of specific modules (e.g., Module 5) as needed.
• "Continuous Publishing" is a critical feature that automates the publishing of documents as they are associated with the content plan or as related content/attributes are updated within the system, ensuring real-time readiness and efficiency.
• The platform supports the creation of cross-document link annotations, converting internal hyperlinks within and between documents into standard relative PDF links, which is essential for maintaining navigability and integrity in regulatory submissions.
• "Continuous Validation" provides real-time verification of eCTD submissions against health authority validation criteria, allowing users to review and resolve errors and warnings (e.g., missing submission contacts) concurrently with the submission process.
• Users can manage the lifecycle state of both the overall content plan (e.g., Draft to Baseline to Complete) and individual documents, ensuring that the correct and approved versions are included in the final submission.
• The system allows for direct submission to various global health authorities via a secure Gateway, with automatic tracking and attachment of acknowledgments received from the Gateway transmission to the submission record.
• The Submissions Archive Viewer serves as a crucial review tool, enabling users to verify that all hyperlinks are functional and document lifecycle states are appropriate before sending the submission to the agency.
• Flexibility is provided in naming conventions for submissions, adapting to diverse business processes, and the system allows for granular control over XML operations on individual "leaves" within the submission outline.
• Documents can be associated with the content plan via simple drag-and-drop functionality, even if they are not yet in an "approved" state, offering flexibility in the authoring and assembly workflow.
• The system streamlines the process of tracking health authority questions and managing changes to marketed product submissions, providing a centralized platform for regulatory interactions.

Tools/Resources Mentioned:

• Veeva Vault Submissions Publishing
• Submissions Archive Viewer
• Gateway (for direct submission to health authorities)

Key Concepts:

• Submissions Publishing: An end-to-end process within Veeva Vault that manages the content planning, publishing, and finalization of electronic submission content for health authorities.
• Content Plan: A structured, template-driven outline that defines all the documents and modules required for a specific regulatory submission, dynamically populating from the submission record.
• Continuous Publishing: An automated capability that continuously publishes documents as they are associated with the content plan or as their attributes are updated, ensuring the submission is always up-to-date.
• Continuous Validation: A real-time feature that verifies eCTD submissions against health authority validation criteria, identifying and allowing for immediate resolution of errors and warnings.
• eCTD (Electronic Common Technical Document): The standard format for submitting regulatory information to health authorities (implied by "health authority validation criteria" and "eCTD submissions").
• Cross-document Link Annotations: Hyperlinks created within and between documents that are automatically converted to standard relative PDF links for compliant regulatory submissions.
• Gateway: The electronic portal or system used to transmit regulatory submissions directly to health authorities.