SafetyDocs Demo Version Control

This video provides an in-depth demonstration of the version control and comparison features within Veeva Vault SafetyDocs, specifically focusing on its application for managing the Pharmacovigilance System Master File (PSMF). The PSMF is a mandatory regulatory document for pharmaceutical companies operating in the EU, and the demonstration highlights how Vault facilitates audit readiness and compliance by meticulously tracking changes across document versions. The core context revolves around the "templated binder concept," where users utilize yellow virtual folders within the system to organize and house country-specific or core EU PSMF documents. As users check documents out, make revisions, and check them back in, Vault automatically manages the Version Control process, creating a robust audit trail.

The presentation first details the native version comparison feature for individual documents within the PSMF binder. By navigating to the version history, users can select any two versions—for instance, version 4.0 compared to version 3.0—to instantly generate a side-by-side comparison report. This report visually highlights the differences: deleted information is marked in red, and newly added information is marked in blue. The speaker provides a concrete example showing how a change in a contact’s street address is clearly flagged, demonstrating the system’s utility in quickly identifying granular content changes without manually reviewing entire documents. This capability is foundational for ensuring that only approved and tracked changes are incorporated into regulated documentation.

The most critical feature demonstrated is the ability to manage and compare versions of the overarching, merged PSMF document. A fundamental requirement of PSMF management is the ability to concatenate numerous "child" documents (potentially 50 or more) contained within the binder into a single, cohesive PDF file, ready for internal review or submission to an auditor. Vault SafetyDocs automates this merge process, creating a master document complete with a title page and a dynamic table of contents. Crucially, this merged document also maintains its own version history. The speaker illustrates how to compare two versions of this merged master file (e.g., version 5 vs. version 4). Because the merged document is a compilation of its children, changes in the underlying documents necessitate updates to the master file's table of contents and content sections. The comparison feature tracks these systemic changes, showing, for example, updates to the logbook section (page 153) where old entries are deleted (red) and new entries are added (blue), thereby proving the integrity and traceability of the entire regulatory file.

Key Takeaways: • Automated PSMF Binder Management: Vault SafetyDocs utilizes a templated binder concept with virtual folders, streamlining the organization and assembly of the complex Pharmacovigilance System Master File (PSMF), which is essential for EU regulatory compliance. • Native Document Version Comparison: The system provides an immediate, visual comparison between any two versions of a document, highlighting deleted content in red and added content in blue, significantly reducing the manual effort required for change control review. • Granular Change Tracking: The version comparison feature is highly specific, capable of identifying subtle changes such as a single street address update within a contact record, ensuring that all revisions are transparent and traceable. • Merged Master Document Creation: Vault facilitates audit readiness by allowing users to merge dozens of individual documents within the PSMF binder into a single, concatenated PDF file, complete with a title page and table of contents, suitable for submission or internal review. • Version Control for Merged Files: Unlike simple PDF merging tools, Vault SafetyDocs maintains a version history for the master merged document itself, allowing regulatory teams to compare changes between different iterations of the complete PSMF submission package. • Tracking Systemic Changes: Comparing versions of the merged PSMF document reveals systemic changes, such as updates to the table of contents or the addition/deletion of entire sections, which are consequential changes driven by updates to the underlying child documents. • Audit Trail Integrity: The comprehensive version control and comparison features provide a robust, automated audit trail, which is critical for demonstrating compliance with GxP and other regulatory requirements during inspections. • Efficiency in Regulatory Review: The ability to quickly identify differences between versions eliminates the need for reviewers or auditors to read through entire documents, dramatically accelerating the internal review and quality assurance processes. • Workflow Integration: The PSMF binders themselves are integrated with workflows, suggesting that the system manages the entire lifecycle of these critical regulatory documents, from drafting and review to final approval and versioning.

Tools/Resources Mentioned:

• Veeva Vault SafetyDocs
• Veeva Vault (General Platform)

Key Concepts:

• Pharmacovigilance System Master File (PSMF): A detailed description of the pharmacovigilance system used by a marketing authorization holder (MAH), required for regulatory compliance, particularly in the European Union.
• Templated Binder Concept: A structured organizational framework within Veeva Vault that uses virtual folders to ensure all required documents for a specific regulatory file (like the PSMF) are collected and organized correctly.
• Version History Comparison: The automated process of comparing two specific versions of a document or binder to visually identify and track all content changes.
• Merged PDF/Concatenated Document: The feature allowing the system to combine all individual documents within a binder into a single, cohesive PDF file for ease of review and submission.