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Don’t let your Veeva Vault Regulatory issues snowball into bigger problems

With Anette Esbensen, Principal Advisory Consultant at NNIT

Is managing regulatory documents, drug submissions and registrations in Veeva more complex than your organization anticipated? Implementing and running Veeva Regulatory Suite without an experienced partner can often cause critical issues that only get worse with time.

In our work as a Veeva partner to the life sciences industry, we at NNIT often encounter organizations who are struggling to manage their regulatory affairs in Veeva Vault.

At first glance, Veeva’s Vault Regulatory Information Management (RIM) suite is a great boon to pharma companies in their efforts to keep track of documents, submissions to Competent Authorities and product registrations. By gathering critical regulatory systems like your electronic document management system (EDMS) and registration system (RIMS) into one platform, Veeva RIM Suite allows you to replace a host of different systems and software tools. And with all your regulatory data stored in one single place, you will achieve better data integrity.

The problem is that it is easy to underestimate the complexity involved when implementing and using Veeva Vault RIM Suite. Companies implementing Veeva RIM Suite without the assistance of an experienced partner like NNIT frequently make assumptions that can make it much harder to achieve the anticipated benefits.

– One of the reasons why a partner with in-depth knowledge of both Veeva Vault and pharma business processes is so important is that you usually need to “translate” Veeva’s regulatory terminology and functions to match those used in the client’s organization. Many of the terms used by Veeva are similar to those used in a typical pharma company, but they often mean different things, Anette Esbensen, Principal Advisory Consultant at NNIT, explains.

Increased focus on maintenance and updates

While getting everything right at implementation is obviously important, pharma companies are also paying more attention to maintaining and updating their Veeva RIM suite: and with good reason.

– When issues with Veeva RIM Suite are not properly addressed, they tend to snowball, creating a backlog that becomes harder and harder to manage. In general, more users are beginning to understand that Veeva RIM Suite is like a living organism that needs to be continually nurtured and adapted: especially in connection to new procedures and regulations, says Anette Esbensen.

Often, there is a need to adjust Veeva RIM Suite to match your internal processes and vice versa. The real trick is knowing who needs to adapt.

– It can sometimes be difficult for a pharma company to fully grasp their own responsibilities when working with Veeva RIM Suite. What can you expect Veeva to deliver? What processes do you need to change internally and how should you prioritize your resources?  This is where a partner like NNIT is able to step in to provide guidance and ask all the right questions, both during implementation and after go-live, because we know both the life sciences industry and Veeva’s Vault suites, says Anette Esbensen. 

“When issues with Veeva RIM Suite are not properly addressed, they tend to snowball, creating a backlog that becomes harder and harder to manage.”

– Anette Esbensen, Principal Advisory Consultant at NNIT

Valuable lessons about Veeva RIM Suite

As a leading Veeva partner, NNIT has participated in more than 450 completed Veeva projects. We know that aligning the whole organization for a new paradigm of continuous improvement is essential for success.

Among other things, our vast experience with Veeva RIM Suite has taught us that it is important to

  • Prioritize starting small: For organizations with limited resources, implementing a few sub-elements of the Veeva RIM Suite platform is usually better than trying to gather everything at once. Begin by identifying the areas where migrating to Veeva provides the most value and use standard templates and best practices to keep customization to a minimum.
  • Replace documents with data: With Veeva RIM Suite, you are often able to work at data level, meaning that you can send data packages instead of producing pdf documents. This enables greater use of automation and machine-to-machine communication.
  • Not underestimate change management: Training and organizational change management are essential – and often overlooked – prerequisites for ensuring trust in the data integrity and quality of Veeva RIM Suite.
  • Get a trusted partner to cover your blind spots: Success with Veeva RIM Suite requires continuous work and a long-term focus. This is much easier to achieve with the assistance of an experienced partner that can apply both life sciences insights and hands-on Veeva experience.