Regulatory requirements are a formidable challenge for early stage biotechs and top pharma alike. As health authorities continually revise guidelines across diverse markets, companies are tasked with swift adaption to changing regulations. The cost of non-compliance is high: recalls and sanctions may gravely harm a company’s reputation, especially in an industry where patient trust is paramount.
What is Veeva Vault RIM?
In this dynamic landscape, Veeva Vault RIM (Regulatory Information Management) emerges as a solution capable of improving traceability, accelerating product approvals, and streamlining regulatory processes. This Software-as-a-Service can enable life sciences companies to plan and prepare global submissions, report on registered products, and even send submissions directly through the gateway. Although there are myriad competitor products capable of supporting regulatory management, Vault RIM’s key differentiator is its ability to enable all these processes in a centralized system, which minimizes data redundancy and improves real-time accuracy of regulatory information.
With regulations in constant evaluation and change, your Vault RIM environment should similarly evolve. It is critical to periodically assess the health of your Vault to ensure it enables regulatory teams to be efficient and compliant.
Improve Performance with Veeva Vault RIM Optimization Strategies
To optimize Vault RIM for better performance, companies can adopt the following strategies:
Harmonize Processes
Streamlining business processes and reducing time inefficiency are arduous efforts, but they start with establishing a feedback channel for each functional group. Does your approval workflow satisfy CMC’s needs, but create a bottleneck for Regulatory Affairs? Do teams struggle to search and filter registration metadata? Begin documenting business pain points. With Vault RIM’s high degree of configurability, clear articulation of as-is and ideal to-be processes allows companies to tailor the system to their specific needs. With expert Veeva Vault guidance, you can optimize the system to better align with teams’ needs and facilitate their day-to-day work.
Identify Key Performance Indicators
Metrics including submission cycle times, document time-to-approval, and adherence to regulatory timelines quantify your organization’s performance and aid in identifying areas of improvement. With Veeva’s reporting capabilities, you leverage both out-of-the-box and customized reports to analysis KPIs and even schedule daily reports. Not only does this help your organization drive accountability, but it also highlights progress and demonstrates system impact to stakeholders.
Leverage Connectors & Integrations
Frequently, documents, study, and product data require collaboration across regulatory and clinical departments. Change controls and events also entail information exchange between regulatory and quality. Veeva offers Vault RIM to Clinical Operations and Vault Quality to RIM Connectors to coordinate these respective processes. Third party integrations can also enable connection between disparate systems. Consider leveraging APIs to schedule data extracts to integrate with more enhanced custom reporting and analytics tools (e.g., Power BI). As a result, teams reduce duplicative data, avoid falling back on manual uploads, and identify a single source of truth.
Customize Your RIMS Vault
Because every organization uniquely adapts to evolving regulations, configuration can go a long way in streamlining regulatory processes. Controlled document templates to expedite document authoring, VQL to enforce business logic, and content plan templates to auto-generate relevant submission sections are just a few examples of upgrades that promote efficiency in your Vault RIMS environment. Too much customization, however, can cause overcomplexity and unnecessary limitations. Any proposed changes should be assessed judiciously and undergo documented change control. Systems that are highly configured may require more rigorous impact assessment in adopting future Vault functionality.
Optimize User Management
As part of your organization’s go-live preparation, we recommend establishing user governance early on. System administrators should have a clear process for ending collaborative sessions, reassigning tasks upon offboarding, etc. APIs are a powerful tool in this context, as they may be utilized to bulk update records, activate/inactivate users, or route and cancel workflows. For bulk user creation, leverage loader sheets to create users and user role setup records, if applicable. Security management is often neglected and tedious, but optimization in this area can prevent critical timeline delays.
Key Takeaways
In conclusion, biotech and pharma companies can unlock the full potential of their Veeva Vault RIM systems by embracing harmonization, data-driven decision-making, connections/integrations, efficient system configuration, and robust user management. By implementing these strategies, organizations can navigate regulatory complexities with agility, reduce time-to-market, and enhance overall compliance.
Do you need help optimizing your Veeva Vault RIM for optimal performance? Contact us to speak with one of our technology experts today.
