Vault Registrations digitizes product registration management within a single cloud-based system, enabling medtech companies to easily plan, track and report on product registrations in one place. With dynamic dashboards and automated reports, the product registration software gives regulatory affairs teams complete oversight and control of all current and planned market activities and Health Authorities' commitments.
Improved data quality by reducing data duplicates and discrepancies
Better visibility into the marketing status of a company’s global product portfolio
Faster responses to Health Authorities through query and commitment tracking
Connection to a unified Vault RIM Platform of applications that improves end-to-end process efficiency
Manage registration information for marketed products and investigational devices including UDI identifiers, device classifications, indications, packaging specifics, and manufacturing details. Manage license updates and renewals and report on the latest approved details.
Track proposed changes to global registrations. Determine the impact of a proposed change and delegate actions to local affiliates to execute the change in their market.
Create easy, self-serve reports showing information by any combination of attributes including product, application, region, manufacturer and more. Address any bottlenecks or delays by re-assigning tasks or sending reminders directly from within the report.
Encourage local user adoption with a specific user interface that allows market product owners to view all country-specific data points in a simple graphical format with quick-launch buttons to update local data.
A Global Application for Product Registration Tracking
Industry Insight: Current State of Modernization in Regulatory Affairs
Streamlining Reg Ops & Data within a Single Source at Baxter
Jay Crowley: UDI Demands on Medtech Organizations