DocShifter Automation in Veeva Vault Auto QC & Fixing of PDF Content

This video provides an in-depth demonstration of leveraging DocShifter for automated Quality Control (QC) and remediation of PDF documents directly within the Veeva Vault environment. The core purpose is to ensure that documents—which often contain critical information for regulatory submissions or internal quality processes—adhere to stringent formatting and technical standards before they proceed through a lifecycle workflow. The demonstration highlights the ability to identify numerous technical flaws in a PDF, such as incorrect versioning (e.g., 1.6 instead of 1.7), missing font embedding, disabled fast web view optimization, improperly configured hyperlinks (wrong color, incorrect zoom settings), and structural issues like overly expanded bookmarks or incorrect initial view settings.

The process is initiated by setting a trigger within the Veeva Vault workflow, allowing users to choose between generating a detailed QC report or automatically fixing the file. In the initial phase, the system analyzes the PDF and generates a comprehensive report detailing all failed checks. This report provides granular feedback on compliance issues, including whether the file size exceeds health authority limits, if it is password protected, and specific details on hyperlink and bookmark errors. For instance, the report identifies hyperlinks that are the wrong color (red instead of blue) and notes that initial view settings are not set to the required default. The ability to customize which checks are performed means the solution can be tailored to meet specific regional or organizational regulatory requirements.

Following the reporting phase, the demonstration shows the remediation capability. By setting the trigger to "fix," DocShifter processes the document and creates a new, compliant rendition—a "QC fixed copy"—while leaving the original source document untouched. This fixed rendition automatically corrects all identified issues. Specific corrections demonstrated include updating the PDF version to 1.7, enabling fast web view, embedding all used fonts, correcting hyperlink colors to blue, setting hyperlink magnification to "inherit zoom," and collapsing bookmarks to only show the first level. This automated fixing capability drastically reduces the manual effort and risk associated with preparing documents for regulatory review, ensuring technical compliance without human intervention.

Key Takeaways: • Automated Regulatory Compliance: The solution automates the technical compliance checking of PDF documents, which is crucial for regulatory submissions (e.g., eCTD) where specific PDF standards (like versioning and font embedding) must be met to avoid rejection by health authorities. • Veeva Vault Integration: The automation is seamlessly integrated into the Veeva Vault workflow, triggered by document lifecycle state changes, allowing for mandatory QC checks before documents move to critical states like "In Review" or "Approved." • Dual Functionality (Report vs. Fix): Users can configure the system to either generate a detailed QC report highlighting all failures or to automatically generate a fixed, compliant rendition, offering flexibility based on the document's stage and required governance. • Critical PDF Standards Checked: The system verifies essential technical requirements, including PDF versioning (e.g., ensuring 1.7), optimization for fast web view, password protection status, and adherence to file size restrictions often imposed by regulatory bodies. • Font Embedding is Mandatory: A key failure point identified is the lack of font embedding; the system ensures all fonts used in the document are embedded in the PDF, guaranteeing that reviewers without those specific fonts can still view the document correctly. • Hyperlink and Bookmark Remediation: The automation corrects common formatting errors such as incorrect hyperlink colors (changing red to blue), setting the hyperlink magnification to "inherit zoom," and fixing over-expanded bookmark structures to display only the top level upon opening. • Non-Destructive Workflow: The fixing process is non-destructive; it creates a new "QC fixed copy" rendition rather than modifying the original source document, preserving the audit trail and original content integrity. • Customizable Checks: The system allows administrators to define which specific checks are run, enabling tailoring of the QC process to align with different health authority requirements or internal GxP standards.

Tools/Resources Mentioned:

• Veeva Vault: The enterprise content management platform used by life sciences companies for managing regulated documents.
• DocShifter: The automation tool used to perform the PDF Quality Control and remediation functions.
• Adobe Acrobat: Used to verify the successful remediation of the PDF properties (e.g., version, fast web view, font embedding).

Key Concepts:

• Rendition: A specific version or format of a document stored within Veeva Vault (e.g., the original source file, a PDF copy, or in this case, a "QC fixed copy").
• Fast Web View Optimization: A PDF setting that optimizes the file for quick viewing over the web by structuring the file content for byte serving, allowing the first page to load before the entire file is downloaded.
• Inherit Zoom: A setting for hyperlinks and bookmarks that dictates the magnification level when jumping to a new location, ensuring the view is appropriate for the target content.
• Font Embedding: The process of including the font data within the PDF file itself, ensuring the document displays correctly regardless of the viewer's installed fonts—a critical requirement for regulatory submissions.