As a leading Veeva Vault partner, NNIT has participated in more than 450 completed Veeva projects. In this article series, some of our experts share their insights and experience from the various Veeva Vault suites.
With widespread adoption of the Veeva Vault platform, the life sciences industry has acquired a powerful tool to unify its data and streamline critical business processes. But there are plenty of pitfalls and challenges when working with Veeva Vault, and many organizations have encountered more difficulties than they expected.
At NNIT, we know that taking the right approach, managing expectations and preparing properly are key prerequisites for success. Below, our experts share their most valuable lessons learned about the Veeva Vault suites for Safety, Regulatory, Clinical and Quality.
Veeva Vault Safety
NNIT expert: Jesper Borgstrøm, Advanced Advisory Consultant
“The right mindset can make a substantial difference in how quickly your organization 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’s not a plug and play solution. Some specific features and options aren’t available without customization. Fortunately, using industry best practices and pre-configured templates, it’s possible to implement Veeva Vault Safety very quickly.”
Veeva Vault Regulatory
NNIT expert: Anette Esbensen, Principal Advisory Consultant
“It’s easy to underestimate the complexity involved when implementing and using Veeva Vault RIM suite. You usually need to “translate” Veeva’s regulatory terminology and functions to match those used in your own organization. Many of the terms are similar but have different meanings.
To maximize the value of the Veeva Vault RIM suite, it’s also important to focus on updates and new releases. Veeva Vault RIM Suite is like a living organism that needs to be continually nurtured and adapted. If issues are not properly addressed, they tend to snowball, creating a backlog that becomes harder and harder to manage.”
Veeva Vault Clinical
NNIT expert: Michael Agard, Team Leader Clinical Consulting USA
“Even though Veeva Vault Clinical reduces the burden of data and document management, while also streamlining communication between the CRO and the clinical trial sponsor, we still see organizations running clinical trials using spreadsheets. One reason for this is the complexity involved with making changes halfway through a lengthy clinical trial. This is a significant barrier for adoption of Veeva Vault Clinical.
Some pharma companies also make the mistake of underestimating the importance of good data governance and management. For example, some have over-customized the Trial Master File Reference Model, which increases both the risk of manual errors and the time spent on managing the trial data. Often, it’s simply due to old habits within the organization.”
Veeva Vault Quality
NNIT expert: Charlotte Øbakke, Head of Quality, Europe
“Quality management touches upon all GxP-related business processes applied across the entire organization. Herein lies much of the complexity of implementing Veeva Vault Quality. To succeed, you have to define a clear framework and logical structure that will enforce consistency across the entire organization.
Training is a good example of an area where experience and knowledge of both the Veeva Vault Quality suite and how to develop an effective learning environment can make a substantial difference. An effective training program that defines business processes, roles, learning objectives, effectiveness checks and suitable training methods is key to achieving an effective learning culture.”