TFS: Veeva Vault Safety Implementation

This video details the implementation experience of Veeva Vault Safety by TFS, a life sciences organization, providing a deep dive into the structured methodology, challenges encountered as an early adopter, and the realized benefits for both internal teams and external clients. The implementation was systematically executed across four key phases: Project Planning and Discovery, Solution Design and Configuration, Testing and Validation, and Training and Deployment. Strong project management was emphasized from the outset to define the core implementation team, establish oversight mechanisms, and ensure the project remained on track and within budget while keeping relevant project sponsors informed.

The Solution Design and Configuration phase was highly collaborative and iterative. After developing user requirements, TFS worked closely with Veeva through a series of remote and face-to-face workshops to configure the system. A key advantage noted was the frequency of Vault Safety updates, which allowed TFS to engage with Veeva regarding requested functionality that might not have been in the initial offering but was scheduled for an imminent planned release. The Testing and Validation stage leveraged Veeva’s established validation of the core architecture, while TFS focused on validating their specific configuration of Vault Safety. This phase concluded with the critical migration of all existing client data into the new Vault Safety platform.

Despite the inherent complexity of setting up and migrating a new system with extensive client data, the implementation was described as highly rewarding, attributed largely to the high degree of responsiveness and support from the Veeva team. A crucial aspect of the deployment involved proactive client communication; TFS met with each client to explain the rationale for the move, demonstrating how the transition aligned with a broader technology strategy. Initial feedback from clients was overwhelmingly positive, particularly concerning the promise of direct access to their data within the new system. Overall, the move to Vault Safety was positioned not just as a system upgrade but as a strategic alignment tool enabling improved efficiency, modern user experience, and enhanced collaboration capabilities.

Key Takeaways: • Structured Implementation Approach: The successful transition utilized a four-phase methodology—Planning/Discovery, Design/Configuration, Testing/Validation, and Training/Deployment—underscoring the necessity of a defined, sequential process for large-scale regulated software rollouts. • Iterative Configuration and Vendor Engagement: The design process relied heavily on iterative configuration cycles involving frequent remote and in-person workshops, allowing the client to provide continuous feedback and engage with the vendor (Veeva) to influence or track functionality planned for future releases. • Validation Strategy in Regulated Environments: While the core architecture of Vault Safety is validated by Veeva, the implementing organization must focus its validation efforts specifically on its custom configuration of the system to ensure regulatory compliance (e.g., GxP, 21 CFR Part 11). • Proactive Client Communication is Critical: Successful adoption required meeting with clients individually to explain the strategic rationale for the system change, demonstrating how the move aligned with broader organizational goals and performing system demonstrations to alleviate anxiety associated with change. • High Vendor Responsiveness Mitigates Early Adopter Risk: As an early adopter of Vault Safety, the implementation was challenging, but the high degree of responsiveness and support from the Veeva team was crucial in making the process smoother and more successful. • Direct Data Access is a Key Client Benefit: One of the most positively received aspects by clients was the ability to gain direct access to their data within the new system, mitigating previous challenges associated with data accessibility and transparency. • Focus on Process Improvement and Workflow: Vault Safety enables the organization to improve internal processes and workflows, leveraging the system’s modern user interface (commented on positively by both staff and customers) and intuitive design. • Enhanced Oversight through Visualization: The system’s visualization capabilities provide improved oversight of the data within the system, offering actionable business intelligence and supporting better decision-making in safety operations. • Efficiency Gains via Gateway Reporting: The implementation is expected to deliver improved efficiency for customers through features such as gateway reporting, which streamlines data submission and retrieval processes. • Future Collaboration Model: The system facilitates new ways of collaborating with partners, aiming for reduced reliance on email exchange and supporting more rapid information and data sharing, leading to deeper integration between the organization and its clients. • Deployment Strategy: The deployment utilized a "train the trainer" approach for system basics, followed immediately by a period of "hypercare" to ensure immediate support and address post-go-live issues effectively.

Tools/Resources Mentioned:

• Veeva Vault Safety
• Existing System (migrated from)

Key Concepts:

• Hypercare: A defined period immediately following the go-live of a new system, during which intensive support is provided to users to quickly resolve issues and ensure smooth adoption.
• Train the Trainer: A training methodology where a small group of internal experts are trained on the new system, who then become responsible for training the wider user base.
• Gateway Reporting: A feature within pharmacovigilance systems designed to streamline the reporting and submission of safety data, enhancing efficiency and compliance.