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.
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:
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:
John is a leader within Kalypso’s PTC and Life Sciences practices, where he focuses primarily on delivering digital transformation results to medical device manufacturers. He leads Kalypso’s RIMS service line, which provides solutions and services to help Life Sciences companies manage product registrations, regulatory submissions, and global UDI submissions.