Gain Real-time Visibility of PSMF-related Documents

This video provides an in-depth demonstration of leveraging dashboards and reporting capabilities within Veeva Vault SafetyDocs to achieve real-time visibility and control over Pharmacovigilance System Master File (PSMF)-related documentation. The presentation emphasizes the importance of robust metrics, Key Performance Indicators (KPIs), and oversight management, specifically addressing the requirements outlined in GVP Module 2. The core focus is on transforming static regulatory compliance requirements into dynamic, actionable operational insights, allowing Qualified Persons for Pharmacovigilance (QPPVs) and PSMF managers to proactively manage the health and status of their critical safety documentation.

The demonstration highlights several key operational dashboards designed to monitor the compliance lifecycle of PSMF documents. A primary feature is the ability to track documents that are "at risk," "overdue," or "late," ensuring timely adherence to regulatory deadlines. The system manages documentation through "virtual binders," which are collections of documents organized by country, region, or core PSMF components. A crucial operational metric is the tracking of periodic reviews—a scheduled cadence (e.g., monthly) for reviewing these binders. The dashboards provide granular visibility into the workload of the user community, showing who is assigned specific review tasks and the completion status of their work. Furthermore, the system offers a high-level view of the overall "health" of each binder, categorizing documents by status (draft, in review, approved).

A significant portion of the video is dedicated to the practical mechanics of generating and utilizing these reports. The presenter illustrates the system's native reporting capabilities, noting that some reports are available "out of the box," while others can be custom-created. The platform allows users to drill down into specific data points by clicking on dashboard widgets or blue hyperlinks, leading directly to the relevant binder or document. Beyond real-time viewing, the system supports scheduling reports (e.g., every Monday at noon) and distributing them via email, PDF, or Excel, facilitating communication with stakeholders outside the immediate system. The process for creating custom reports is straightforward, enabling users to define criteria using field attributes specific to PSMF, Boolean quantifiers, and lists of values, ensuring the output is tailored to specific oversight needs, including the addition of calculated fields and customized output columns.

Key Takeaways: • Proactive PSMF Oversight: The primary value proposition demonstrated is shifting PSMF management from a reactive, audit-driven process to a proactive, real-time operational function, allowing managers to identify and mitigate risks associated with late or overdue regulatory documents immediately. • GVP Module 2 Alignment: The reporting structure is explicitly designed to support the requirements of GVP Module 2, focusing on the centralized management, control, and oversight of the Pharmacovigilance System Master File documentation. • Virtual Binder Management: The system utilizes "virtual binders" to organize PSMF-related documents by region, country, or core component, providing a flexible yet structured approach to managing the complex collection of required regulatory artifacts. • Workload and Resource Management: Dashboards offer critical insights into the user community's workload, detailing assigned, in-progress, and completed tasks, which is essential for resource allocation and ensuring timely completion of periodic reviews. • Periodic Review Cadence: The system supports the establishment and tracking of periodic review cadences (e.g., monthly reviews) for all PSMF binders, enforcing a consistent schedule for maintaining document currency and compliance. • Document Health Status: Managers gain immediate visibility into the overall health of each PSMF binder, categorized by document status (e.g., approved, in draft, in review), enabling rapid identification of bottlenecks in the review and approval workflow. • Drill-Down Capabilities: The interactive nature of the dashboards allows users to "drill down" from high-level metrics (widgets) directly to the underlying documents or binders, facilitating rapid investigation and resolution of compliance issues. • Custom Report Generation: The platform provides intuitive tools for creating bespoke reports by defining criteria using PSMF-specific field attributes, Boolean logic, and calculated fields, ensuring that reporting output meets unique organizational or regional compliance needs. • Automated Distribution: Reports can be scheduled for automated delivery (e.g., weekly emails) and exported in multiple formats (PDF, Excel), streamlining the process of disseminating compliance metrics to QPPVs, management, and other non-system users. • KPI Focus: Key performance indicators revolve around timeliness (overdue/late status), completeness (binder health), and efficiency (user workload), providing measurable data points for continuous process improvement in pharmacovigilance operations.

Tools/Resources Mentioned:

• Veeva Vault SafetyDocs (Implied platform)
• Veeva Vault (General platform ecosystem)

Key Concepts:

• PSMF (Pharmacovigilance System Master File): A detailed description of the pharmacovigilance system used by the marketing authorization holder (MAH), required under EU legislation (GVP Module 2).
• GVP Module 2: Good Pharmacovigilance Practices Module 2, which specifically governs the requirements for the PSMF.
• QPPV (Qualified Person for Pharmacovigilance): The individual legally responsible for the establishment and maintenance of the company's pharmacovigilance system.
• Virtual Binders: A system construct used to group and manage related regulatory documents (in this context, PSMF components) for easier review and oversight.
• Boolean Quantifiers: Logical operators (AND, OR, NOT) used in custom report creation to precisely define the data criteria for inclusion in the report output.