Regulatory affairs professionals at large medical device companies must manage heavy submission workloads, registrations for products currently on the market, and ever-changing regulatory requirements. Many RA teams are still relying on paper documents, spreadsheets, and other outdated tools and methods to complete this work, while others have taken steps toward digitization and automation of key processes.
Regulatory teams often struggle to find software tools designed specifically for them. Because the processes they manage are typically product-focused, RA teams may attempt to use software built for product design and engineering teams, including product lifecycle management (PLM) systems.
Product lifecycle management (PLM) applications provide a central system for managing everything from the design of a new product to testing and ongoing maintenance. PLM systems are typically used by multiple teams, including product design and engineering teams, to coordinate product-related processes. The core elements of a PLM system include:
PLM software can be considered both a data warehouse and a secure project system. PLM systems are used for storing and retrieving all product design-related information; including version-specific manufacturing (CAD) drawings, specifications, and supplier requirements. These systems also manage the workflows associated with each stage of a product’s lifecycle, from the design process to product maintenance to end of life activities. For medical device manufacturers, the PLM system is typically where design history files and device master records are maintained.
Regulatory information management (RIM) systems have been around for years in the pharmaceutical industry but are relatively new in the medical device industry. Holistic RIM systems enable users to create a single source of truth for all data associated with regulatory submissions and registration management. RA teams are able to focus on critical tasks by using RIM systems to digitize data and automate key processes.
RIM system functions are designed to support a range of regulatory activities across a product’s lifecycle. In addition to centralizing core regulatory data and managing regulatory registrations and certificates, RIM systems can also support:
RIM systems also tend to be product-centric, structuring data around individual regulated products, but are focused on saleable products, components, and packages where PLM systems are focused on the manufactured items. This means that RIM systems can track product-specific data, such as sales status by country, and link standards with individual products to easily identify products affected by standards updates and assess their impact.
PLM systems will often be integrated with ERP systems to ensure the correct bills of material and other product details for the current version of the product are being used by the manufacturing system. PLM systems can also be integrated with eQMS (quality management systems) and RIM systems to ensure coordination of risk management activities, product updates, and quality data between the regulatory, quality, and product teams. Ideally, your regulatory team should be notified as early as possible of any planned updates or changes to a product that is in-market or pending market approval.
Digitization and automation of regulatory data are more critical as global regulations continue to change and become more complex. Getting a medical device to market is a difficult process, but RIM software cuts the time and costs associated with product registrations while providing tools essential for ensuring ongoing compliance. PLM systems are critical as well, but their focus on product design and other product details simply does not provide the functionality needed by regulatory teams. Integrate a strong PLM system with a holistic RIM system to give both your engineering and regulatory teams the tools they need to bring your products to market successfully and to maintain compliance. To get your regulatory ducks in a row, only a RIM system will do!
To learn more about the Rimsys RIM system, talk to one of our experts today.