Life sciences companies are facing rapidly changing and increasingly complex regulatory requirements around the world. Examples include the new European Union’s Medical Device Regulation (EU MDR) and the growing list of countries that require Unique Device Identification (UDI) submissions. While necessary to ensure product safety and efficacy, these regulatory forces are in direct opposition to companies' goals of bringing new products to market faster (and in more countries) and maintaining compliance over time as products and regulations change.
To solve these challenges, medical device and pharma companies are turning to digital technology in the form of regulatory information management systems (RIMS). RIMS manage regulatory data and processes such as product submissions, product registrations, UDI submissions, and post-market surveillance. These regulatory processes and data span the entire lifecycle of a product, so naturally they are interwoven with other product data and processes, including design, manufacturing, sales, and monitoring. In other words, regulatory data is product data. However, today's regulatory systems are typically isolated to their own island, used only by regulatory experts and separate from other product management systems such as product lifecycle management (PLM) and enterprise resource planning (ERP).
To get more value out of regulatory data, an increasing number of life sciences companies are turning to a new generation of RIMS solutions, built directly inside PLM platforms such as PTC Windchill.
The benefits of RIMS in PLM
Why are companies turning to PLM for RIMS when there are already so many mature RIMS point solutions on the market? Here are just a few of the many reasons:
- Easier and better integration: Standalone RIMS solutions must be integrated to product data that resides in other systems, such as part numbers (SKUs) needed for production registrations, part metadata needed for UDI submissions, product requirements that may be regulatory in nature, and mountains of technical documentation needed for regulatory submissions. By contrast, PLM systems already have most of that data (and can easily integrate to other systems as needed). And more importantly, PLM is the system used to execute change control of product data, including change impact assessments. This means regulatory impact assessments that require regulatory data can be directly integrated in product change processes. And it means that regulatory experts can easily compile submission packages using the latest and greatest versions of product data, instead of spending countless hours struggling to compile information and then keep it up to date as it changes in a separate system.
- Fewer systems to learn and maintain: With RIMS built-in to PLM, end-users have one less system to learn and use, and IT has one less system to implement and maintain. And now, everyone who uses PLM can easily see the regulatory data too, as opposed to only regulatory experts using a separate RIMS approach.
- More advanced capabilities: Many of the core capabilities provided by standalone RIM systems are simply inferior to the sophistication and configurability of those same capabilities in PLM. For example: document management, workflow management, reporting, searching, role-based access controls, approvals, and security. These are the "bread and butter" of a PLM system like Windchill.
Perhaps the best way to summarize the main advantage of RIM in PLM is the term "enterprise enablement" as used by Gartner in this diagram:
While "holistic platform" solutions may have slightly less mature functionality for some regulatory-specific functions, the overall benefits they provide to the enterprise make them exceedingly valuable to life sciences companies bringing new products to market.
For more on how to enhance your regulatory strategy, visit Digital Regulatory Information Management