Registrations: Creating/Submitting/Approving a Non-data Submission

This video provides an in-depth exploration of the process for creating, submitting, and approving non-data regulatory submissions within Veeva Vault, a critical platform for regulatory affairs in the life sciences industry. The presenter guides viewers through a practical, step-by-step workflow, using the example of a product registration transfer to illustrate the various stages of a regulatory action. The core purpose is to demonstrate how to efficiently manage administrative documents and their associated metadata, ensuring compliance and streamlined operations within the Veeva ecosystem.

The tutorial begins by outlining how to initiate a new regulatory action from an existing registration, emphasizing the critical initial data entry and the distinction between non-data submissions (which typically don't require a binder) and data submissions (which do). It then delves into the meticulous process of dossier management, covering how to edit dossier titles, add administrative documents by uploading them directly into Veeva, and efficiently manage metadata for multiple documents. A significant portion of the video focuses on document lifecycle management, detailing two methods for releasing documents from a draft state to a released state—both in bulk using a "cart" feature and individually—underscoring the flexibility of the platform.

As the regulatory action progresses, the video demonstrates how to transition its state from draft to submitted, highlighting the automatic updates that occur for related objects like labels and dossiers when only a single dossier is involved. It also addresses scenarios where changes might be requested by a competent authority, explaining how to create additional dossiers to accommodate such revisions. Finally, the tutorial covers the crucial step of documenting approval by uploading all relevant correspondence and approval letters into the "received documents" section, culminating in the final approval of the regulatory action. Special attention is given to the additional steps required for product transfers, including documenting historical registration details and updating new product involvement information.

Key Takeaways:

• Veeva Vault as a Central Regulatory Hub: The video demonstrates Veeva Vault's integral role in managing regulatory submissions, acting as a centralized platform for creating, tracking, and approving regulatory actions and associated documents.
• Structured Regulatory Action Workflow: Users are guided through a clear, sequential process for initiating a new regulatory action, filling in essential data, and navigating it through various lifecycle states from creation to final approval.
• Distinction Between Submission Types: The tutorial highlights the difference between "non-data submissions" (often administrative, not requiring a binder) and "data submissions" (which necessitate a binder), influencing initial setup choices within Veeva.
• Efficient Dossier and Document Management: The process of adding administrative documents to a dossier is detailed, including uploading files from a local drive and associating them with the specific regulatory action.
• Strategic Metadata Application: Emphasis is placed on the importance of comprehensive and accurate metadata for each document. The video showcases how to efficiently apply metadata in bulk to multiple documents, with options for subsequent individual edits to save time and ensure consistency.
• Document Lifecycle State Management: The concept of document states (e.g., draft, released) is explained, along with practical methods for transitioning documents between these states, including bulk "direct release" actions and individual document releases.
• Automated Workflow Transitions: Veeva Vault automatically updates the lifecycle states of related objects (like labels and dossiers) when a regulatory action is moved to "submitted" or "approved," streamlining the workflow, though this automation is limited to single-dossier scenarios.
• Handling Competent Authority Change Requests: In cases where a competent authority requests changes, the video demonstrates how to create additional dossiers by copying existing records, allowing for revisions and resubmissions without disrupting the original submission record.
• Comprehensive Documentation of Approval: Post-submission, it is crucial to upload all correspondence from the competent authority, including the final approval letter, into the "received documents" section to maintain a complete audit trail.
• Specifics of Product Registration Transfers: For product transfers, additional steps are required to document the transfer history (historic registration number, company, transfer date) and the new product involvement, ensuring a clear record of ownership and regulatory responsibility.
• User Responsibility for Data Accuracy: The presenter stresses that users are the experts in their submissions and should fill out metadata as comprehensively and accurately as possible, as there typically isn't a secondary checker for this information.
• Modular Training Approach: The video indicates that more complex topics, such as the specific lifecycle states and version control for labels or managing scenarios with multiple dossiers, are covered in separate, dedicated training modules, suggesting a structured learning path for Veeva users.

Tools/Resources Mentioned:

• Veeva Vault: The primary platform demonstrated for managing regulatory actions and submissions.
• Cart Feature: Used for selecting and performing bulk actions on multiple documents within Veeva Vault.

Key Concepts:

• Regulatory Action: A container within Veeva Vault that encompasses all activities and documents related to a specific regulatory submission or change for a product.
• Non-data Submission: A regulatory submission that primarily involves administrative documents (e.g., application forms, cover letters) rather than scientific study data.
• Dossier: A collection of documents submitted to a regulatory authority as part of a regulatory action.
• Competent Authority: The regulatory body responsible for reviewing and approving submissions (e.g., FDA, EMA).
• Metadata: Descriptive information about a document (e.g., registration number, product name, document type, language) that aids in organization, search, and compliance.
• Document Lifecycle State: The current status of a document within Veeva Vault's workflow (e.g., Draft, Released, Submitted, Approved).
• Direct Release: A process within Veeva Vault to transition a document from a draft state to a released state, making it available for submission.
• Registration Transfer: The process of transferring the regulatory registration of a product from one company or entity to another.

Examples/Case Studies:

• Registration Transfer Process: The primary example used throughout the video is the transfer of a product registration from "Bear" to "Envu," illustrating how to manage the regulatory action, documents, and approvals associated with such a transfer.