With Jesper Borgstrøm, Advanced Advisory Consultant at NNIT
Veeva’s Vault Safety Suite represents a new generation of safety systems for the life sciences industry. However, lessons learned from NNIT’s extensive Veeva consultancy show that organizations should also recognize the complexities involved in achieving the desired benefits.
Compared to traditional on-premise safety systems, Veeva’s Vault Safety Suite provides strong options for scalability, automation, signal detection and master data management. In addition, Veeva is usually much faster to implement and can be up and running in 18 to 36 weeks, depending on your choice of features and the complexity of your organization and IT landscape.
But, as several pharma companies have discovered, unlocking the potential value of Veeva Vault Safety requires time, effort and attention to detail. When implementing Veeva Vault Safety, you should be prepared to adjust your business processes, especially if you are coming from a legacy system where things work differently.
In the experience of Jesper Borgstrøm, Advanced Advisory Consultant at NNIT, the right mindset can make a substantial difference in how quickly organizations can realize a satisfactory return on investment with Veeva Vault Safety.
– I always ask clients who are considering Veeva Vault Safety, “Are you ready to change?” Veeva Vault Safety is a great tool, but it is important to manage your expectations and plan carefully to achieve the optimal results. You need to be a bit more proactive and know how to avoid making common errors during both implementation and use, says Jesper Borgstrøm. Companies neglect good data governance
Not a plug and play solution
A key experience for Jesper Borgstrøm in his work with Veeva Vault Safety is that there is a time and a place for everything. Veeva Vault Safety can be relevant for all life science organizations, but there are many factors and characteristics to be considered. This is why it is important to use an experienced partner like NNIT, who can help you make the right choices before, during and after implementation.
– Veeva Vault Safety is a perfect match for a large section of the market. However, it is not a plug and play solution. Some specific features and options are not available in Veeva without customization, Jesper Borgstrøm explains and continues:
– Fortunately, it is still possible to implement Veeva Vault Safety very quickly using industry best practices and pre-configured templates. NNIT recently assisted one of our pharma clients with implementation including user training and organizational change management, and we were able to complete the project from start to finish in just 18 weeks.
Keep up with constant improvements
Veeva Vault Safety is still under development, and users should expect Veeva to add a lot of new features and improvements over the coming 12-18 months. This underlines the importance of being prepared to handle the continuous updates, both in terms of keeping your system validated, but also to adapt your organization to take advantage of the new options.
– I imagine we will see Veeva Vault Safety play a similar role to Veeva’s Vault RIM suite, which is more automated and optimized out of the box. This means that there is an opportunity to reduce manual tasks and optimize workflows, if you are ready to adjust your procedures, says Jesper Borgstrøm.
“I always ask clients who are considering Veeva Vault Safety, “Are you ready to change?” Veeva Vault Safety is a great tool, but it is important to manage your expectations and plan carefully to achieve the optimal results.”
– Jesper Borgstrøm, Advanced Advisory Consultant at NNIT
Valuable lessons about Veeva Vault Safety
As a leading Veeva partner, NNIT has participated in more than 450 completed Veeva projects. We know that aligning the whole organization with a new paradigm of continuous improvement is essential for success.
Some of our lessons learned about Veeva Vault Safety include
- Great for meeting the latest standards: Because Veeva Vault Safety has been designed with the ICH’s latest E2B (R3) standard for electronic transmission of individual case safety reports (ICSRs) in mind. This makes handling signal detection and master data management significantly easier.
- Key settings require customization: A significant amount of configuration and customization should be expected to achieve the maximum value of Veeva Vault Safety. For instance, the standard configuration of the Veeva Vault Safety suite only supports reporting to the FDA and EMA. Reporting to regulatory agencies outside the United States and Europe requires customization. The same is true for periodic reporting, reporting templates, expectedness calculation, automations and gateways. Validation of all these features also requires some measure of customization.
- Integrations have room for improvement: While Veeva Vault Safety has many options for integration with other Veeva Vault suites such as RIM, Quality and Clinical, only a few provide a truly unified experience out of the box.
- Upcoming features require attention: Expect Veeva Vault Safety to evolve significantly over the next few years. Consider allying with a partner to ensure continuous data optimization and a deeper understanding of the Vault Safety Database Structure to manage master data and ensure correct transformation of data throughout your organization.
