Seven KPIs to measure regulatory information management
As a leading global medtech innovator, GE Healthcare was looking to consolidate 10-plus disconnected sources of information into a single, connected system to operate faster, while ensuring compliance. With over 19 years of regulatory operations experience, James Hendry, Head of Global Regulatory Operations at GE, understood that the introduction of a cloud-based regulatory information management (RIM) solution was necessary to achieve these goals. After implementing a RIM suite, James identified seven unique ways to measure the value of a modern RIM solution.- Streamlined cross-functional activities – Automated task handoffs significantly reduce the number of emails and spreadsheets needed throughout endless share folder locations. Everything in one system provides a “single source of truth”, providing better visibility and instilling confidence in data.
- Time saved – The ability to create and update records in bulk for multiple country registration activities saves a ton of time. Creating 130 country records for one activity previously took several hours; now that activity takes only minutes
- Enhanced collaboration – Moving away from manual tasks and sharing files from drives and multiple locations simultaneously eliminates misinformation and collaboration errors. By leveraging automated tasks and a single system for content storage, teams at GE can be confident knowing they are always collaborating on current data.
- Faster data access – Stakeholders used to have to create forms manually and email them to the data entry team to be entered into the system, causing delays and potential errors. Now, they can enter data independently once, avoid duplication, and it is immediately available for access.
- Instant reporting – Historically, thousands of products over 130 countries took hundreds of hours to report. With RIM, a single report can be instantly generated to show all approvals and renewals, saving approximately 200 hours of work per year.
- Reallocate resources – Leveraging this modern solution GE empowered their valuable regulatory resources, who were previously bogged down with manual administrative tasks, to focus on core competencies, bringing strategic value to the business and product development.
- Better decisions with clear KPIs – GE can now identify bottlenecks with a full 360-degree view into processes that they previously knew were inefficient but didn’t know the severity of impact or where to target. Their RIM allows management to quickly pivot strategies focused directly on the largest impact.
Brian Scogland is director of regulatory strategy at Veeva MedTech