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. For most, managing regulatory activities creates several challenges: struggling with poor data quality, duplication, and limited visibility as a result of disjointed processes and a myriad of tolls for each task. Add in new regulations like EU MDR and IVDR with a global pandemic and the complexity is compounded.

This is why executives from leading device and diagnostics manufacturers came together at Veeva Summit to share their successes and best practices for modernizing regulatory technology and processes. The ability to innovate while complying with ever-changing requirements proved to be a consistent theme across the board, 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 have enabled companies to harmonize their regulatory functions, globally, and move with greater speed. Moving away from manual processes with limited visibility to utilizing systems that create transparency and the ability to share real-time data is resulting in more efficient submission development, better compliance, and speed.

At Summit, Baxter Healthcare shared their RIM implementation best practices and approach to modernizing regulatory operations. The speaker outlined the company’s project scope, guiding principles, and measurements of success for how RIM centralized regulatory operations into one tool and is part of a larger ecosystem of data and documents.

Enable Compliance

Complying to 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 When operating with outdated tools and processes, the risk of a mismanaged process can lead to serious financial penalties, product delays, and a tarnished corporate reputation.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, advanced 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 Alcon and others at Summit, a unified RIM platform facilitates better access, visibility, and control over regulatory documents and data processes in real-time.

Single Source of Truth

Regulatory teams across an organization need to be connected throughout the product lifecycle by maintaining a single source of truth that feeds critical commercial processes. With regulatory 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.

Adopting a single, connected commercial application as a “source of truth” was echoed throughout Summit as a solution to ensure teams collaborate on the latest version, shorten regulatory review times, and bring a compliant message to market with speed unparalleled to previous disconnected systems.

Roche Diagnostics elaborated on this by sharing best practices to implement and utilize technology for a single, connected source of truth with better 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. We heard this loud and clear from GE Healthcare, who shared how a cloud-based solution 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 or where to target a remedy. With RIM, management at GE is now able to quickly pinpoint inefficiencies and pivot strategies targeted at the biggest impact.

Reiterated by other device and diagnostic companies, 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’s critical for companies to reduce complexity, streamline regulatory operations and compliance processes, globally, to stay competitive. To learn more and watch on-demand sessions from companies leading the way in modernizing regulatory, register here.