Regulatory Information Management (RIM) refers to a category of software solutions that are designed to support and streamline the activities of regulatory affairs (RA) teams. For most teams they are a net-new category of software, and generally replace manual processes that are paper-based or run using traditional productivity software (spreadsheets and docs). RIM systems first emerged to support pharmaceutical regulatory activities, but in recent years medtech-focused solutions have hit the market as well.
Given their general new-ness, especially for medtech RA teams, it’s not surprising that many teams are unfamiliar with the technology. In our, admittedly informal, survey of RAPS 2021 attendees, only 11% of respondents said they currently use a RIM system, and 33% had no knowledge of the category at all. This article provides some background on what RIM systems are, and what they do to help medtech RA teams operate more effectively.
To understand RIM systems, first we have to look at the role of regulatory affairs. In medtech, which includes medical devices, in vitro diagnostics, and medical software, RA teams play a critical role across a product’s lifecycle.
Before products are released for sale, RA teams work closely with research and development (R&D) teams to ensure that a new product meets necessary local requirements to be legally marketed in the desired target markets. There are over 113 different regulatory regimes around the world that medical devices are subject to. While there are many similarities, RA teams must understand the nuances between countries and guide R&D to ensure that products are developed accordingly.
Once products obtain market clearance, RA teams switch to monitoring mode to ensure that products can remain on the market. This includes keeping track of expiration dates and certificates, any changes in regulations or international standards that could impact the product, and any changes in the product or it’s technical documentation. Health authorities in many countries regularly perform product audits, so keeping all information in order and up-to-date is an important part of regulatory work.
RA teams usually take the lead on post-market surveillance activities as well, working closely with their quality assurance (QA) counterparts. They track adverse events and complaints, compiling this information from public and internal sources, and ensure that the data is reported appropriately to health authorities. Not all markets require extensive post-market surveillance for medical devices, but these regulations are becoming more common. Both the EU and Canada have recently implemented expanded surveillance requirements including the need for regular summary reporting to continuously confirm product performance and safety.
All of the regulatory activities highlighted in the previous section are repeated for every individual product the company sells in every regulated country or region. And, all of these activities are highly dependent on specific information. To do their jobs effectively, medtech regulatory affairs professionals need insight into global regulations and standards, detailed product specifications, testing, performance, and safety data, and a full record of all regulatory registrations and processes.
The problem is that this information is often scattered across the company. It’s stored in multiple systems, (sometimes physical) documents, and individual employees’ heads. Because this information is so scattered, RA professionals can spend up to 50% of their time just looking for things, and simple requests such as identifying whether a product has clearance to be marketed in a specific country can take days to complete.
At a fundamental level, RIM systems are about helping RA teams corral and manage all of the information they need to do their jobs. RIM systems serve as a “single source of truth” for RA teams. They store and manage regulatory documents, integrate with systems across the company, and create a traceable record of all regulatory activities. All of this information is linked to individual products and countries or regions, making it much easier to find.
All of the collected information in a RIM system can be used to streamline regulatory activities across the product lifecycle. Before products are released, they provide access to regulatory intelligence, including market entrance requirements, that RA teams can use to guide product development and regulatory submissions. RIM systems also provide a collaborative digital hub where teams can author and assemble supporting documentation for new regulatory submissions.
For products currently on the market RIM systems can monitor registration expiration dates, and track changes in relevant standards and regulations to identify potential product impacts. This automated monitoring can give RA teams an “early warning”, and allow them to accommodate changes that might impact the selling status of a product.
RIM systems can also help with post-market surveillance activities. They can collect and centralize post-market data analytics, and facilitate planning and active surveillance activities to meet the most current regulatory requirements. These systems can also ensure that actions and conclusions drawn from the post-market surveillance process are consistently applied throughout the quality management system. And, the same authoring capabilities used to assemble pre-market submissions can be used for post-market reporting and communication with regional regulatory authorities.
Underpinning all of these capabilities is a full set of project features that allow RA teams to effectively manage and track their activities. This can include project request features that allow internal teams or 3rd-party partners such as local distributors to request specific regulatory activities or information. RIM systems also provide project task management, approval workflows, and digital signature capabilities that are fully auditable, and 21 CFR Part 11 compliant.
RIM systems also provide detailed reporting in the form of customized dashboards and registration, product, standards, and documentation reports. These reports offer at a glance monitoring of key information and detailed visibility into regulatory status and activities. For many teams this level of visibility is new, and allows them to fully measure, benchmark and report on their activities to company leadership.
RIM systems can have a tremendous impact on RA teams. By centralizing information they improve team productivity by ensuring that up-to-date information is always easily available and consistently applied. By automating workflows like new submission creation, or essential principles/GSPR table assembly they ensure that work gets done quickly and in-line with country/region requirements. RIM systems also provide more visibility into regulatory activities, allowing teams to benchmark and more accurately forecast the time required for new market clearance, and other product milestones.
To the company, the increased regulatory efficiency and effectiveness means reduced revenue risk from noncompliance or having to pull products from market, stronger, more confident global regulatory compliance, and ability to get new products to market much more quickly.
To learn more about RIM systems, their key capabilities, and if your organization could benefit from bringing one onboard, read our RIM System Buyer’s Guide for Medtech Companies.