A regulatory information management system (RIMS) helps streamline submissions and ensure compliance. But not every RIMS is the same. In the blog, we look at Vault RIM to see whether it can be the solution for your regulatory needs.
Whether your focus is on compliance around IDMP data requirements, implementation of company harmonization standards, or setting up master data with fully integrated systems, a regulatory information management system (RIMS) will play a critical role in achieving your goal.
One solution designed to support all three of these goals is Veeva System’s Vault RIM suite. It was built from the ground up as a cloud-based solution utilizing Veeva’s Vault Platform technology.
Vault RIM Suite: 4 Applications
The Vault RIM suite includes four applications that can be purchased together or separately, depending upon your specific needs. Each application has a specific function within the suite:
- Registrations: Managing product registrations and health authority interactions.
- Submissions: Creating and managing submission content as well as submission planning and tracking.
- Submission Publishing: Building compliant submissions and submitting them to health authorities via an electronic gateway.
- Submissions Archive: Storing and viewing the complete history of the regulatory submission.
Vault RIM Functionalities & Offerings
As you evaluate potential RIM solutions, below are some key Vault RIM functionalities and offerings to consider:
- All four RIM applications are seamlessly integrated and function as a single repository. This will significantly reduce the duplication of data and content as well as provide a holistic view of the data and documents.
- The Vault RIM data model has been adapted to accommodate IDMP data elements and reporting requirements.
- The system includes robust reporting capabilities that can join data and documents across all four applications.
- Veeva’s RIMS object model supports both Pharmaceutical and Medical Devices.
- The system administration is designed so that responsibilities can be separated between System and Business Administrator, allowing the business to take an active role in managing business-specific functionality.
- Features such as In-line editing (the ability to update object fields in the viewer without opening the record) and bulk updating can significantly reduce the time end-users spend on data entry.
- Vault can be configured to receive emails and their attachments directly, making it a quick way to capture and store communications with health authorities or third-party vendors.
- Veeva offers validated pre-built connectors allowing their Clinical, Quality, and PromoMats Vaults to connect directly to the Vault RIM suite. These connectors can further reduce duplication of documents/data and support harmonization and integration efforts.
- Veeva has three major releases each year, so you can be confident that your system will include the necessary functionality to stay compliant, as well as enhancements to improve the user experience.
- As a cloud-based solution, Veeva provides IQ and OQ validation testing and documentation as part of their support model, thus reducing your internal validation activities so you can focus on user acceptance testing.
Implementing Vault RIM: What You Need to Know
As part of your evaluation and implementation discussions, you will also want to pay close attention to those areas that may impact the adoption and rollout of your Vault RIM.
For example, the Veeva document library does not use a folder/file hierarchy. Instead, it relies on documents being correctly classified and the appropriate meta-data being assigned. This makes for robust searching and reporting capabilities; However, your team will need to properly document their data and reporting needs (including IDMP data elements).
Publishing
Veeva’s Submission Content Planning tool is a departure from traditional publishing tools. Include time to develop content plan templates specific to your business needs and ensure all users have the necessary training so that they can take full advantage of the solution.
Security
Veeva’s security is robust, allowing for very simple to extremely complex security configurations. Before implementing the system, take time to fully document your company’s specific security needs. Be sure to consider third-party vendors as well as future growth in your assessment.
Implementation
Regardless of your reason for implementing a registration management system, be prepared for a significant amount of work preparing documents and data for migration into the new system. Consider using a third party and/or migration tool to assist with this activity.
If integration is part of your end goal, be sure to develop system governance to oversee all integrated systems and clearly document ownership, triggers, and dependencies.
If you are implementing RIM as a standalone system, you will need to develop processes to ensure your data stays up to date and accurate. This is especially true when dealing with IDMP data elements that are not owned by regulatory.
Conclusion
Whether your focus is on compliance, harmonization, or fully integrated systems, Veeva Vault should be considered during your RIMS evaluation. Vault RIM’s applications and functionality provide a powerful solution for your regulatory needs.
Daelight Solutions is a Veeva Vault GxP Systems Migration Partner that has extensive tools and skills required to migrate your content and data to Vault. Contact us to see how we can help you figure out whether Vault RIM is right for your company.