Veeva Vault RIM Submission Publishing Overview : How Vault Submission Publishing Works

This video provides an in-depth overview of Veeva Vault RIM Submission Publishing, detailing its features and workflow for managing electronic submissions to health authorities. The speaker introduces the module as a comprehensive solution designed to streamline the content planning, publishing, and finalization processes required for regulatory submissions. The primary goal is to ensure compliance with evolving regulations by leveraging pre-configured actions and specialized capabilities within the Veeva Vault platform. The discussion emphasizes how the system handles content, which includes documents and required details, from preparation through to submission, enabling users to manage changes for both new and existing marketed products.

The presentation then delves into specific features that enhance the efficiency and accuracy of the submission process. Key functionalities highlighted include "link publishing," which automatically converts internal document references into functional PDF links upon publication, and "continuous publishing," allowing documents to be published automatically as they become part of a content plan or as related content is updated. A crucial aspect is "continuous validation," where the system automatically checks if submissions meet health authority criteria (e.g., eCTD format), providing immediate feedback on errors or warnings. The video also covers "publishing status indicators," visual cues that inform users about the progress and state of their submissions, and "document and object lifecycle user actions," which enable users to manage the states of content plans and items from draft to final approval.

Finally, the speaker outlines the step-by-step process for working with submission publishing. This typically involves preparing content, creating a submission record, developing a content plan (a collection of documents), initiating the publishing process, and then proceeding through document release, internal review, validation, and correction stages. This structured workflow is essential for situations like introducing new products or making significant changes to existing ones, where a collection of relevant documents needs to be submitted for approval. The video concludes by mentioning the "gateway feature" for direct submission to health authorities and the "submission archive viewer" for accessing published documents, underscoring the end-to-end capabilities of Veeva Vault RIM in regulatory affairs.

Key Takeaways:

• Veeva Vault RIM Submission Publishing offers a complete process for handling content planning, publishing, and finalization of electronic submissions to health authorities, ensuring regulatory compliance.
• The system allows users to create "content plans," which are collections of documents and associated details necessary for submission, particularly for new product introductions or updates to existing products.
• "Link publishing" is a key feature that automatically transforms internal references within Veeva Vault documents into functional PDF hyperlinks when content is published, enhancing navigability and accuracy.
• "Continuous publishing" enables documents to be published automatically as they are added to a content plan or as related content undergoes changes, reducing manual effort and accelerating the submission timeline.
• "Continuous validation" is crucial for compliance, as it automatically checks submissions against health authority validation criteria (e.g., eCTD format) and provides real-time feedback on errors or warnings.
• "Publishing status indicators" (e.g., green, half-orange, orange circles) provide visual cues on the submission record, indicating whether content is published, in progress, or has pending validation or errors.
• "Document and object lifecycle user actions" empower users to manage the states of content plans and content plan items, allowing transitions from draft to baseline, logged, or complete states, and enabling actions like inactivating items.
• The overall workflow for submission publishing involves creating a submission record, preparing content, building a content plan, initiating publishing, and then proceeding through document release, internal review, validation, and correction before final submission.
• The "gateway feature" facilitates direct submission of finalized content to health authorities, where permitted, and allows for the reception of acknowledgements and attachments, streamlining communication.
• The "submission archive viewer" provides a centralized location for users to view and access published documents, ensuring transparency and easy retrieval of submitted materials.
• The system is designed to reduce the need for manual checks by automating publishing and validation processes, thereby increasing efficiency and reducing the risk of human error in regulatory submissions.

Tools/Resources Mentioned:

• Veeva Vault RIM
• Veeva Vault Submissions Publishing module
• Submission Archive Viewer

Key Concepts:

• Content Plan: A collection of documents and associated details required for a regulatory submission.
• Link Publishing: A feature that converts internal document references into functional PDF hyperlinks during the publishing process.
• Continuous Publishing: Automated publishing of documents as they become part of a content plan or as related content is updated.
• Continuous Validation: Automated checking of submission content against health authority validation criteria (e.g., eCTD) to ensure compliance.
• Publishing Status Indicator: Visual cues (e.g., colored circles) that denote the current status of a submission's publishing and validation process.
• Document and Object Life Cycle User Action: User-initiated actions to change the state of documents, content plans, and content plan items within Veeva Vault.
• eCTD (Electronic Common Technical Document): A standard format for submitting applications, amendments, supplements, and reports to regulatory authorities. The video mentions checking against "dosier format" like eCTD.
• Health Authority: Regulatory bodies (e.g., FDA, EMA) to whom pharmaceutical and life sciences companies submit regulatory documents.

Examples/Case Studies:

• Submitting documents for the introduction of a new product.
• Submitting documents for changes or updates to an existing marketed product.