Gain Control of Your Safety Documentation

This video provides an in-depth exploration of Veeva Vault SafetyDocs, a web-based document management system purpose-built for pharmacovigilance (PV) content and global collaboration within the life sciences industry. The application is highlighted as being 21 CFR Part 11 and Annex 11 compliant, addressing a critical need for regulated document control. The presenter, Scott EML, demonstrates the core functionality, starting with the home area which uses color-coding (e.g., orange for documents nearing their due date) to provide immediate visibility into pending tasks. Notably, the system is designed to work harmoniously with, or standalone from, the core Vault Safety application, allowing users to see both documents and associated safety cases that require processing.

The heart of the application is the Library, which manages documents based on user permissions and security roles, ensuring that users only see content relevant to their workflow stage (e.g., draft, review, effective). The system supports a wide array of document types, including Word files and others, and utilizes flexible filters to allow users to quickly slice, dice, and save views, facilitating easy retrieval of specific content like Pharmacovigilance System Master File (PSMF) documents. The presentation emphasizes that Vault SafetyDocs is intended to be an organically growing system that supports four major PV-related document use cases.

The four primary use cases detailed include the management of the Pharmacovigilance System Master File (PSMF), which utilizes an out-of-the-box binder template structured with sections 1 through 7 and Annexes A through I, allowing for customization of the binder structure as needed. The second use case focuses on contractual PV-related documents, such as Safety Data Exchange Agreements (SDAs) and Pharmacovigilance Agreements (PVAs), which require specialized metadata like start and end dates. The third major area is the creation, editing, authoring, review, and approval of Aggregate Reporting documents, facilitating cross-collaboration by inviting regulatory teams and even sharing documents externally via CrossLinks with other Vaults for consumption in filings like INDs or NDAs. Finally, the fourth use case centers on Inspection Readiness, Risk Mitigation (Rams, RMPs), and signal monitoring documentation.

The system’s architecture supports sophisticated document control through virtual collections called "binders." A single document can exist in multiple binders simultaneously. Both binders and individual documents can possess their own distinct workflows and life cycles, allowing for tailored processes (e.g., a contract document having a different workflow and metadata than a PSMF section). Critical features demonstrated include robust metadata association, version history, check-in/check-out functionality, and simultaneous collaboration, enabling multiple users or partners to work on the same document concurrently. All this structured metadata is leveraged to create native, actionable reports and dashboards, eliminating the need for third-party query tools. Users can point-and-click to create custom reports on aggregate statuses, document timelines, and ownership, which can then be converted into dashboards, drilled down for detail, and scheduled for automated delivery to stakeholders.

Key Takeaways:

• Regulatory Compliance Foundation: Vault SafetyDocs is explicitly designed to meet stringent regulatory requirements, being 21 CFR Part 11 and Annex 11 compliant, which is essential for managing audit trails and electronic signatures in pharmacovigilance documentation.

• Harmonious System Integration: The application is built to work seamlessly with Veeva Vault Safety, allowing users to view both safety cases requiring processing and associated safety documents from a unified home area, streamlining PV operations.

• Structured PSMF Management: The system provides a dedicated, structured approach for managing the Pharmacovigilance System Master File (PSMF), offering an out-of-the-box binder template that organizes the required sections and annexes while maintaining flexibility for customization.

• Four Core PV Use Cases: The platform is optimized for four major document types: PSMF, PV-related contractual agreements (SDAs, PVAs), Aggregate Reporting documents, and Inspection Readiness/Risk Mitigation documentation (RMPs, signal monitoring).

• Metadata-Driven Workflow Customization: Different document types (e.g., contracts vs. aggregate reports) can be assigned unique workflows, life cycles, and metadata fields (such as start/end dates for contracts), ensuring appropriate governance for varied content.

• Binder Flexibility and Coexistence: The "binder" feature acts as a virtual collection, allowing a single document to be pointed to and co-exist in multiple binders simultaneously without duplication, simplifying organization across different regulatory requirements or projects.

• Simultaneous Collaboration: The platform supports concurrent editing and collaboration, allowing multiple internal colleagues or external partners (e.g., sponsors and CROs) to work on the same document at the same time while maintaining version control and history.

• External Collaboration via CrossLinks: Vault SafetyDocs facilitates external data sharing through "CrossLinks," enabling documents created within one Vault to be securely consumed by external partners or regulatory teams using another Vault for filings like INDs or NDAs.

• Native Business Intelligence and Reporting: The system eliminates the need for third-party BI tools by offering native capabilities to create custom, point-and-click reports and dashboards based on all associated document metadata (e.g., status, timelines, ownership).

• Actionable Dashboards: Reports can be converted into dashboards that provide a high-level view (30,000-foot view) of document statuses (e.g., aggregate report statuses), allowing users to drill down into specific document categories or timelines for actionable insights.

• Automated Report Scheduling: Reports can be scheduled to run automatically and arrive at a specified destination (user group or email) on a defined schedule (e.g., every Friday at noon), ensuring timely dissemination of critical compliance and operational data.

Tools/Resources Mentioned:

• Veeva Vault SafetyDocs
• Veeva Vault Safety
• CrossLink (Veeva functionality for sharing documents between Vaults)

Key Concepts:

• 21 CFR Part 11/Annex 11 Compliance: Regulatory standards governing electronic records and electronic signatures, critical for pharmaceutical systems.
• Pharmacovigilance System Master File (PSMF): A detailed description of the pharmacovigilance system used by a marketing authorization holder, required for regulatory submission and inspection readiness.
• Aggregate Reporting: The periodic compilation and analysis of safety data from clinical trials and post-marketing surveillance (e.g., PBRERs, DSURs).
• Binder: A virtual collection of documents within the Veeva Vault platform, used to organize content for specific purposes (e.g., regulatory submissions, contractual agreements).
• Risk Management Plan (RMP): A set of pharmacovigilance activities and interventions designed to identify, characterize, prevent, or minimize risks relating to a medicinal product.