Documents: Uploading a Document

This video provides a step-by-step guide on uploading documents directly into the document library of Veeva Vault, a critical content management system in the life sciences industry. The presenter focuses on the direct upload method via the 'documents' tab, acknowledging that other upload avenues exist through regulatory actions or study modules. The primary objective is to demonstrate the process from initial document selection to its final release within the system, emphasizing the crucial role of metadata and proper workflow management for compliance and traceability.

The tutorial meticulously walks through the user interface, starting with navigating to the documents tab, selecting 'create,' and then 'add document.' It highlights the importance of choosing the correct upload option, specifically for documents originating from a desktop or shared drive. A significant portion of the video is dedicated to the metadata entry process, explaining the distinction between required (yellow fields) and optional (white fields) information. The speaker stresses the necessity of accurately completing all applicable fields to ensure high-quality metadata, which is vital for future searchability and maintaining robust documentation standards. Specific metadata fields like file name, full title, document date, author, 'for use in' (country/global/territory), direct release option, language, ownership, confidentiality, and specific product (108 number) and specification (102 number) numbers are detailed.

Following the metadata entry and saving the document, the video explains the document's initial 'draft' state within the Veeva Library. It then covers post-upload functionalities, such as reviewing and editing information, and the ability to attach or link other related documents using the 'relationship' tab. This includes linking different versions, redacted copies, supporting documents, or translations. A key feature discussed is the 'document files' section, which provides the downloadable 'viewable rendition' of the document. The presenter strongly recommends using this viewable rendition when submitting documents to regulatory authorities, as it automatically includes the document number and version, ensuring traceability back to the Veeva system. Finally, the video demonstrates the process of releasing the document, either directly if pre-approved or by sending it for review, ultimately moving it from a draft to a released, version 1 state, making it available for linking with regulatory actions, dossiers, or general use.

Key Takeaways:

• Direct Document Upload Workflow: The primary method demonstrated for uploading documents into Veeva Vault involves navigating to the 'documents' tab, selecting 'create,' and then 'add document,' specifically choosing the option for direct upload from a desktop or shared drive.
• Criticality of Metadata: Accurate and comprehensive metadata entry is paramount for document searchability, organization, and compliance within Veeva Vault. Users must diligently fill out all required (yellow) and applicable optional (white) fields.
• Specific Metadata Fields: Key metadata fields include file name, full title, document date, author, 'for use in' (specifying country, global, or territory), language, ownership, and confidentiality. The video also highlights specific numerical fields for 'products' (e.g., 108 number) and 'specifications' (e.g., 102 number).
• 'Direct Release' Option: Veeva Vault offers a 'direct release' option that allows a document to transition immediately from a draft to a released state, bypassing a formal review workflow if pre-approved. Otherwise, documents can be sent for editing, review, or a standard release process.
• Document States and Version Control: Uploaded documents initially reside in a 'draft' state. Upon completion of the release process, they transition to a 'released' state, typically as version 1, ready for broader use and linking within the system.
• Document Relationships and Linking: Veeva Vault facilitates robust document management through its 'relationship' tab, enabling users to link different versions of a document, redacted copies, supporting documents, or translations, ensuring a comprehensive document ecosystem.
• Importance of the Viewable Rendition: The downloadable 'viewable rendition' of a document, found under 'document files,' is crucial for regulatory submissions. It automatically embeds the document number and version, providing essential traceability back to the Veeva system when submitted to authorities.
• Traceability for Regulatory Submissions: Submitting the viewable rendition to regulatory bodies is a best practice, as it ensures that the document can be unequivocally traced back to its source within Veeva Vault, supporting compliance and audit trails.
• Post-Upload Review and Editing: After initial upload, users can review the entered information and make edits using the pencil icon, ensuring accuracy before the document proceeds through its lifecycle.
• Integration with Other Modules: While the video focuses on direct upload, it acknowledges that documents can also be uploaded through other modules like 'regulatory actions' or the 'study module,' indicating Veeva Vault's integrated nature within broader life sciences operations.

Tools/Resources Mentioned:

• Veeva Vault: The core document management system demonstrated in the video.

Key Concepts:

• Metadata: Data that provides information about other data. In Veeva Vault, it includes details like author, date, title, and usage, crucial for document organization and retrieval.
• Viewable Rendition: A specific, system-generated version of a document (often a PDF) that includes embedded metadata like document number and version, intended for external sharing or regulatory submission to ensure traceability.
• Direct Release: A workflow option in Veeva Vault that allows a document to bypass a formal review process and move directly from a draft to a released state.
• Document States: The lifecycle stages of a document within Veeva Vault, such as 'Draft' (initial state) and 'Released' (final, approved state).
• Document Relationships: The ability within Veeva Vault to link various related documents (e.g., different versions, supporting files, translations) to a primary document, creating a comprehensive information package.