With Anette Esbensen, Principal Advisory Consultant at NNIT
Veeva Vault RIM Suite is excellent for managing regulatory documents, drug submissions and registrations. And the right partner can help you ensure that everything runs smoothly from the start.
A robust and user-friendly Regulatory Information Management (RIM) system can be a great boon for life sciences organizations who are struggling to manage their regulatory affairs.
With Veeva Vault RIM Suite it is much easier to keep track of documents, submissions to competent authorities, and product registrations, because critical regulatory systems like your electronic document management system (EDMS) and registration system (RIMS) are gather in one platform.
This 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.
Get the terminology right from the start
When implementing Veeva Vault RIM Suite, one of the most important focus areas is to ensure that Veeva’s regulatory terminology and functions are matched to those used in your specific organization. The Veeva Vault platform supports all the different needs of a life sciences company, but making assumptions without the guidance of an experienced partner can cause problems.
– Many of the terms used by Veeva are similar to those used in a typical pharma company, but in some cases they can mean different things. That is why you should choose an implementation partner with in-depth knowledge of both Veeva Vault RIM Suite and pharma business processes, Anette Esbensen, Principal Advisory Consultant at NNIT, explains.
Plan for regulatory changes
While getting the implementation right is obviously important, you should also prioritize a long-term strategy for dealing with regulatory changes and updates to Veeva Vault RIM Suite.
– The regulatory landscape in the life sciences industry is like a living organism and pharma companies often have adapt to new procedures and regulations. In this case, you must either adjust Veeva Vault RIM Suite to match your internal processes or vice versa. The real trick is knowing what you need to change and how should you prioritize your resources, says Anette Esbensen.
This is an area where a partner like NNIT can provide guidance and ask all the right questions, also after go-live.
Valuable lessons about Veeva Vault 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 Vault RIM Suite has taught us that it is important to
- Consider starting small: For organizations with limited resources, starting out with specific products like Vault Submissions or Vault Registrations may be better than trying to implement the entire Veeva Vault RIM Suite all at once. Begin by identifying the areas where migrating to Veeva Vault provides the most value and use standard templates and best practices to keep configuration efforts to a minimum.
- Replace documents with data: With Veeva Vault RIM Suite, you are 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.
- Prioritize change management: Training and organizational change management are essential – and often overlooked – prerequisites for success with Veeva Vault RIM Suite.
- Get a trusted partner: Maximizing the value you gain from Veeva Vault 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.
