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RIMS is a growing category of regulatory software solutions designed to help RA teams achieve faster submissions with fewer rejections. However, despite their novel nature, most platforms are already behind the times, technologically speaking. This article discusses the benefits of RIMS and examines how other platforms stand up against RegDesk.
What is RIMS Software, and Why Is It Important?
In highly regulated industries such as MedTech and Pharmaceutical, gaining regulatory approval – and keeping it – is often more difficult and time-consuming than creating the products in the first place. The challenge is the diversity of regulations among different nations. Despite efforts by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to create a comprehensive document for regulatory submissions back in 2000, the resulting Common Technical Document (CTD) only succeeded in harmonizing portions of the pharmaceutical process. However, there’s still an entire module devoted to regional variation in regulations. More recently, the EU MDR and FDA have introduced electronic submissions forms for medical devices that at least consolidate the registration process within the domain of their authority. But there remains a lot of variation in the process of gaining regulatory approval across different international markets.
In response to this problem, software companies have in recent years introduced regulatory information management systems (RIMS) – software that consolidates regulatory data into one platform. These platforms enable users to access regulatory intelligence, create submissions dossiers for diverse markets, and store relevant product data in one place. In addition, many RIMS also offer tracking and alert applications wherein users track submission progress and receive resubmission alerts for devices that have already hit the market.
The true value of RIMS platforms lies in the accessibility of information. In many companies today, regulatory information is still stored in spreadsheets. Different data components necessary to bring medical devices and pharmaceuticals to market often reside in different computers occupying offices on opposite sides of the world. Sharing information is challenging. When it is accomplished, there’s no guarantee that the data is correct. Clerical errors or outdated intelligence shared at the beginning of projects often snowball into submissions rejections. RA teams rely heavily on the experience and knowledge of individual team members. If someone left, they generally took their brains with them, leaving a knowledge gap that would take time to fill. For these companies, RIMS solutions enable faster submissions.
Is RIMS Worth it?
The answer: it depends. It’s not that all RIMS platforms aren’t helpful; they are. The issue is cost vs. benefit: how can you get the most bang for your buck. Most RIMS platforms merely house information collected by RA teams – useful, but it fails to take advantage of new technological innovations that offer a whole new world of speed and quality.
When we say new innovations, we actually mean old innovations that have recently experienced a renaissance: AI applications. Although the basic principles of AI haven’t changed much since IBM’s Deep Blue chess software defeated reigning chess champion Gary Kasparov in 1997, the way industries utilize AI has. In the last 20 years, AI has come to permeate every aspect of our lives. Long before it became popular to tout that an app was “AI-powered,” artificial intelligence was quietly working away, improving industries such as banking, manufacturing, and medical diagnosis since the early 2000s.
Despite general acceptance of artificial intelligence for medical applications, the same technology has received a relatively cold introduction from regulatory affairs teams working within the same industry. This is undoubtedly the result of different personalities and cultures within departments. Medical technology, by necessity, must constantly evolve to meet the needs of patients. The long and established culture of innovation encourages experimentation within that domain of the industry. In regulatory affairs, on the other hand, veracity and rapidity are valued above all. There’s little time for experimentation when navigating the already time-consuming and tedious process of seeking regulatory approval. Whatever the reason, the absence of this technology from the medical device regulatory field means that RA teams are working harder than they need to accomplish less than they could.
This brings us to the value aspect of RIMS. For companies that are still using ancient technology such as spreadsheets, any RIMS platform would be an improvement. But few platforms offer a comprehensive solution to today’s medical device and pharmaceutical regulatory challenges. In this respect, the most important aspect to consider is automation: the extent to which a platform automates the regulatory lifecycle of a medical device. Most platforms automate a small fraction of the process. Usually, that amounts to matching products to the correct regulatory intelligence, standards, and regional partners and distributors. Helpful? Yes. Utilizing the full capabilities of 21st-century software technology? No.
Where RegDesk Comes In
RegDesk is unlike any other RIMS. Rather than being a repository for regulatory intelligence, submissions, and other product information, our platform uses AI software to multiply the efforts of users. Our innovative application builder consolidated the entire submissions process into simple, fillable forms. As the users enter the product information, the software draws from our vast database of regulatory intelligence to autofill the next stages of the application. Clients have reported that our platform has cut their submissions time from months to hours. They’ve also reported significantly fewer rejections because human error has largely been eliminated from the submission process. The result is faster submissions with fewer rejections. Beyond submissions, our platforms automatically match products to relevant standards, consolidate change notifications, and rend important resubmission alerts – all based on submission data. There’s no need for users to find and apply these functions to their products.
If you are considering switching your company’s method of managing regulatory information, RIMS is undoubtedly the way to go. Software platforms have been around for a while; they have probably been managing your banking, healthcare, and social life for years. So, there is no reason not to trust them with Regulatory affairs. The only question is which platform you should go with. On that note, we will leave you with one parting remark: Other platforms do some of what RegDesk does, but no other platform does it all.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.