Documents - Uploading a New Version of an Existing Document to Veeva

This video provides an in-depth exploration of how to upload a new version of an existing document within Veeva, a critical process for maintaining accurate and compliant documentation, particularly in regulated industries. The guide focuses on the specific steps required to update a document while ensuring the previous version is correctly made obsolete, a common necessity when corrections or updates are made to official records such as regulatory submissions, manufacturing methods, or product labels. The presenter walks through the user interface, highlighting common pitfalls and the correct operational path to achieve proper document versioning.

The core of the process revolves around using the "Create Draft" function, which, despite potentially counter-intuitive naming compared to an "Upload New Version" option, is the correct method for generating a new iteration of an existing document. This action ensures that the document retains its original identifier (document number) while incrementing its version number. The guide demonstrates two primary ways to create a new draft: either by uploading an entirely new file to replace the existing content or by directly editing the current document within the system. The former is suitable for complete content overhauls, while the latter is ideal for minor corrections or updates.

Following the creation of a draft, the video emphasizes the importance of reviewing and updating associated metadata, such as regulatory actions or effective dates, which may change with the new document version. Once the content and metadata are finalized, the document is transitioned from "Draft" status to "Release." This "Release" action is crucial as it automatically makes the previous major version of the document obsolete and updates the current document to a new major version number (e.g., from 7.2 to 8). The system then meticulously tracks this version history, providing a clear audit trail of all superseded documents. The presenter further illustrates the direct editing method, showcasing how users can check out a document, make changes using integrated tools like Microsoft Office, and then check it back in, which automatically creates a new minor version (e.g., 8.1) before it can be released as a new major version.

This tutorial distinctly differentiates the versioning process from simply "making a copy" of a document. Creating a copy in Veeva results in an entirely new document number and resets the versioning to zero, which is inappropriate for updating an existing record. The detailed walkthrough provides practical guidance for users to navigate Veeva's document management functionalities effectively, ensuring data integrity and compliance with internal and external regulatory requirements by maintaining accurate and traceable document versions.

Key Takeaways: • Correct Versioning Method: To upload a new version of an existing document in Veeva, users must select the "Create Draft" option, not "Upload New Version," as the latter may not function as intended for this specific process. This is a critical user interface distinction to ensure proper document management. • Preservation of Document Identity: Utilizing the "Create Draft" feature ensures that the document retains its original document number, which is essential for maintaining continuity and traceability within the system. • Version Number Progression: Creating a draft and subsequently releasing it will change the document's version number. A draft typically creates a minor version (e.g., 7.2), and releasing it promotes it to a new major version (e.g., 8), making the previous major version obsolete. • Obsolescence of Previous Versions: Releasing a new version of a document automatically supersedes the prior version, effectively marking it as obsolete in the system's history. This is vital for regulatory compliance and ensuring only the current, approved version is in use. • Mandatory Metadata Review: After uploading new content or making edits, it is crucial to double-check and update the document's metadata, such as regulatory actions or text dates, to reflect any changes associated with the new version. • Two Paths for Draft Creation: Users have the flexibility to either upload an entirely new document file to replace the existing content or to directly edit the document within the system (e.g., using integrated Microsoft Office tools). • Direct Editing Workflow: For direct edits, the process involves checking out the document, making necessary changes in the integrated application, and then checking it back in. Checking in creates a new minor version (e.g., 8.1) before it can be released as a major version. • Importance of Version History: Veeva maintains a comprehensive version history, allowing users to track all previous iterations of a document, which is critical for audit trails and regulatory compliance. • Distinction from "Make a Copy": It is crucial to understand that "Make a Copy" creates an entirely new document with a new document number and resets the versioning to zero, which is different from updating an existing document's version. • Regulatory Compliance Implications: Accurate document version control is paramount in regulated industries like pharmaceuticals, ensuring that only approved and current documents are used for submissions, operations, and audits, aligning with standards like GxP and 21 CFR Part 11.

Tools/Resources Mentioned:

• Veeva: The primary document management platform discussed.
• Microsoft Office: Mentioned as an integrated tool for direct document editing within Veeva.

Key Concepts:

• Document Versioning: The process of creating and managing multiple iterations of a document, tracking changes over time.
• Draft: A preliminary or unreleased version of a document that is undergoing edits or review.
• Release: The action of publishing a finalized draft, making it the current official version and superseding previous versions.
• Obsolete: The status given to previous versions of a document once a newer version has been released, indicating they are no longer current or valid.
• Metadata: Data that provides information about other data, such as regulatory action, text date, and document type, which needs to be updated with new document versions.
• Document Number: A unique identifier for a document that remains constant across its versions.
• Version Number: A numerical indicator that changes with each new iteration of a document (e.g., 7.2, 8, 9).
• Check-out/Check-in: A process in document management systems where a user temporarily locks a document for editing (check-out) and then saves their changes back to the system (check-in), often creating a new version.

Examples/Case Studies:

• Cover letter submitted to an agency: Used as a practical example where a mistake might necessitate re-uploading a corrected version, making the original obsolete.
• Various methods, labels, and other document types: General categories of documents in regulated environments that frequently require version updates.