DocShifter Automation in Veeva Vault - Multiple Global Rendition Creation

This video provides an in-depth demonstration of how to leverage DocShifter automation within Veeva Vault to simultaneously create multiple, globally compliant document renditions from a single source file. The primary goal is to streamline the submission preparation process for pharmaceutical and life sciences companies by eliminating the need for manual manipulation of PDF files to meet varying regional regulatory requirements. The demonstration uses a toxicology written summary document and shows the automated creation of renditions compliant with both the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the U.S. Food and Drug Administration (FDA).

The automation workflow is triggered by changing the document’s life cycle status within Veeva Vault. The speaker illustrates defining a specific trigger status, such as "DocShifter Ready," which the DocShifter workflow monitors. Once the status is changed, the file is picked up, moves through an "In Process" interim status, and then, upon completion, automatically transitions to a final status like "In Review." This process ensures that the document is automatically processed according to predefined rules, taking the original source file and generating two distinct, compliant renditions tailored for different regulatory bodies, all without human intervention.

A core focus of the demonstration is the granular control over regulatory specifications required for each region. For the PMDA-compliant rendition, the system is configured to exclude a Table of Contents (TOC) and apply specific bookmarking rules, such as grouping all tables together at the end of the bookmark tree. In contrast, the FDA-compliant rendition is configured to include a TOC (with defined parameters for when it should be added, such as documents over a certain page count) and maintain a different bookmark structure where tables are scattered throughout the document tree. Beyond structural differences, the automation ensures technical PDF compliance, including setting all hyperlinks to the required blue color, ensuring all links and bookmarks are set to "inherit zoom," embedding all fonts fully, optimizing the file for "fast web view," and setting the PDF version to 1.7.

The flexibility of the solution allows users to define numerous rendition types beyond the viewable rendition standard in Veeva Vault, such as "Compliant Rendition" for the FDA version. While the demonstration focuses on storing the compliant files as renditions attached to the original document, the speaker notes the option to configure the workflow to create the compliant PDF files as entirely new objects within Veeva Vault, offering flexibility in document management strategy. This automated approach drastically reduces the time and risk associated with manually preparing submission-ready documents for multiple global markets.

Key Takeaways: • Automated Global Compliance: The system enables the simultaneous, automated creation of multiple regulatory renditions (e.g., PMDA and FDA) from a single source document, ensuring consistency while adhering to unique regional specifications. • Veeva Life Cycle Triggering: Automation is initiated by leveraging Veeva Vault’s document life cycle statuses; defining a specific status (e.g., "DocShifter Ready") acts as the trigger for the automated rendition workflow. • Granular Regulatory Differences: Compliance requirements are managed through configuration, such as defining specific bookmarking structures (e.g., grouping tables for PMDA vs. scattering them for FDA) and controlling the inclusion of elements like the Table of Contents (TOC). • Conditional TOC Inclusion: The workflow allows for setting specific parameters (e.g., document length, such as over five or ten pages) to dictate when a TOC must be automatically generated and included in the final rendition, catering to varying regional rules. • Technical PDF Compliance: The automation addresses critical technical requirements for regulatory submissions, including ensuring all hyperlinks are the correct color (e.g., blue), setting link properties to "inherit zoom," and embedding all fonts fully. • PDF Optimization Standards: Compliant renditions are automatically optimized for technical standards required by regulatory bodies, such as setting the PDF version to 1.7, ensuring optimization for "fast web view," and correcting initial view settings. • Workflow Status Monitoring: The process includes interim status updates within Veeva Vault (e.g., "In Process") allowing users to monitor the file as it is being processed by the external automation tool before it lands in a final review status (e.g., "In Review"). • Flexible Output Options: The generated compliant documents can be stored either as multiple renditions attached to the original source document or configured to be created as entirely new PDF objects within Veeva Vault, depending on the organization's document management needs. • Elimination of Manual Manipulation: The core value proposition is eliminating the need for manual post-processing of PDF files (e.g., manually adjusting bookmarks, links, or properties) to meet different regional submission standards.

Tools/Resources Mentioned:

• Veeva Vault
• DocShifter
• Adobe Acrobat (used for viewing and verifying compliant PDF properties)

Key Concepts:

• Global Rendition Creation: The process of automatically generating multiple versions of a single document, each tailored to the specific formatting and technical requirements of different global regulatory agencies (e.g., US, Japan, EU).
• Document Life Cycle Status: The predefined stages a document moves through in Veeva Vault (e.g., Draft, Review, Approved, DocShifter Ready), used here to trigger automated workflows.
• Inherit Zoom: A PDF property set on links and bookmarks that ensures the viewer’s zoom level remains consistent when navigating to the linked content, a common requirement for regulatory submissions.
• Fast Web View Optimization: A PDF setting that optimizes the file structure for viewing over the internet, ensuring faster loading and display, often mandated by regulatory guidelines.
• PMDA/FDA Compliance: Adherence to the specific technical and structural requirements for document submissions set forth by the Japanese Pharmaceuticals and Medical Devices Agency and the U.S. Food and Drug Administration, respectively.