Four key areas to streamline regulatory operations and compliance
The medtech industry is changing with today’s regulatory professionals at the center of this evolution. Managing regulatory activities creates several challenges: struggling with poor data quality, duplication, and limited visibility because of disjointed processes. Add in new regulations like EU MDR and IVDR and the complexity is compounded.That is why leading medtech manufacturers are modernizing regulatory technology and processes. The ability to innovate while complying with ever-changing requirements is critical, including:
- Harmonizing regulatory operations
- Enabling better compliance
- Providing a single source of truth
- Streamlining and measuring success
Harmonize regulatory operations
The introduction of cloud-based regulatory information management (RIM) systems is enabling companies to harmonize their regulatory functions globally and move with greater speed. Moving away from manual processes with limited visibility to systems that create transparency and the ability to share real-time data is resulting in more efficient submission development, better compliance, and increased speed to market. A cloud-based RIM solution can centralize regulatory operations into one system and is part of a larger ecosystem of data and documents.Enable compliance
Complying with new regulations is an on-going challenge for most companies. When operating with outdated tools and processes, the risk of a mismanaged process can lead to serious financial penalties, product delays, and a tarnished corporate reputation. Fortunately, modern technology enables regulatory professionals to keep up with a growing amount of global information, quicken the pace of change, and collaborate with more people. As highlighted by this case study on Alcon, a unified RIM platform facilitates better access, visibility, and control over regulatory documents and data processes in real-time.Single source of truth
Various teams including regulatory, quality, and commercial need to be connected throughout the product lifecycle. And with teams tasked with managing ever-increasing volumes of information, including promotional materials, the stakes are too high for errors associated with misinformation across multiple siloed systems. That is why it’s critical to have a single source of truth that feeds commercial processes.Adopting a single, connected commercial application as a “source of truth” ensures teams collaborate on the latest version, shortens review times, and brings a compliant message to market with speed unparalleled to previous disconnected systems. This improves compliance and acceleration of the digital supply chain process of creating, approving, and distributing commercial content across their organization and digital marketing channels.
Streamline and measure
A unified RIM solution empowers organizations to work smarter by streamlining processes and measuring tangible results. GE Healthcare is leveraging a cloud-based solution that allows their leaders to easily identify bottlenecks with a full 360-degree view into the process. Previously, leaders knew there were inefficiencies but had no visibility into the impact.A modern RIM solution also reduces administrative burden and frees up valuable resources for more value-add tasks. GE demonstrated this case by sharing how their affiliates now access one system to update data, rather than previous methods of filling out a form and emailing to HQ for data entry.
The bottom line is it is critical for companies to reduce complexity, and streamline regulatory operations and processes, globally, to stay competitive.
Looking to learn more? Join our MedTech Regulatory Community Meeting on June 17 to hear customer use cases from experts leading digital transformation, engage in live Q&A, and join roundtable discussions. Register today here.
Terri Howard is director of commercial content strategy at Veeva MedTech and Brian Scogland is director of regulatory strategy at Veeva MedTech