As the push for new, comprehensive Regulatory Affairs & RIM platforms reaches fevered heights in the Life Science industry, we took a look at what is enabling successful implementations of the next generation. How do we avoid the classic 3 year cycle and implement a platform that will perform for 5, 10, 15 years? Our discussions put a higher value on clean, plentiful, ordered data than almost any other consideration when creating a RIM system.
The Problem with Software
While it’s tempting as a vendor to highlight the advantages of implementing our software right away, a successful long-term platform must be supported by the right initial data. In short, if your data isn’t ready and usable, your Reg Affairs / RIM solution won’t be as good, so you’re already starting the race behind.
There has been a steady investment in RIM capabilities over the past 5 – 7 years and growing experimentation with traditional and emerging technologies such as robotics, collaborative authoring, artificial intelligence, and structure content management.
Organizations that rank high in our World Class RIM benchmark tend to get more value out of their technology investments as their foundational processes are efficient and more importantly, their data quality levels tend to be higher than the industry average. Applying technology to a strong process and organizational base results in better outcomes and business benefit realization.
– Steve Gens, Founder, Gens & Associates
So while there’s a strong desire to adopt these new technologies and platforms, those who really succeed with them tend to have better quality data, and better business processes already in place.
The Right Data
If the goal is to create a future-proofed solution for Regulatory Affairs using quality data, what should we be focused on? Leonard Lescosky, Vice President of Regulatory Operations & CMC at AbbVie, posed the problem like this:
What is Regulatory Information? We are accustomed to Google organizing all the world’s information and allowing us to find it at will. We want RIM to do that for regulatory information. The trouble with RIM is we want RIM to tell us not only where a product is approved, but where a product is sold and its stock number, and all in a tidy report. I think the key to successful RIM is to manage the minimum amount of regulatory data necessary to direct users to read well-organized applications. A Google search will return a lot of wrong information. We do not want a RIM search to do the same.
Selecting the right data as the core of your future RIM platform is essential – fortunately Generis (in fairness, as well as some of the other leading RIM vendors) can help you adapt to object and data models that have been prepared in line with existing and upcoming industry requirements. As a result, it’s important to begin working with vendors sooner rather than later if you don’t have strong confidence in the quality of your data (whether or not you end up using that vendor’s software or not).
Future-proofing from the Start
So far we’ve talked about improving what we have, and choosing the right data carefully, but in order to ensure we don’t build a spot-solution in the excitement, we need to look forward most of all. I spoke with Remco Munnik, Associate Director at Iperion, to find out whether he thought companies were doing enough to prepare for the implementation of upcoming data standards.
As momentum has been gained with the alignment for TOM and PMS between EMA, National Competent Authorities, it is interesting to see if companies are picking up and accelerating their ISO IDMP activities.
Overall a lot has to be done within a limited period of time: data needs to be collected, verified, entered and eventually submitted; processes need to be amended; technology needs to be updated or implemented.
In addition, companies need to make sure that people are aware of the change and impact of the TOM and ISO IDMP requirements.
Therefore, in my opinion, companies need to start as soon as possible.
While it’s challenging to predict which initiatives will gain prominence in the next decades, we need at least a framework for managing regulatory information that is flexible enough to adapt. In ten years’ time there’ll be a new acronym on everybody’s lips, and we don’t want to have to re-architect once again.
Where to Start
Even those businesses leading the implementation of RIM platforms are favouring an approach of implementing a core RIM platform, and gradually expanding the scope. This could be fairly understandable; the time pressure to prepare for new data standards makes even the most valuable navel-gazing quite risky. But at the core, we’ve identified at least a set of essential steps:
- Engage with a ‘third-eye’ partner that has industry best-practice expertise
- Review existing data and processes
- Select a focused set of data to get started that will enable your business processes and ensure the highest possible quality going forward
- Find a platform that offers the flexibility to adapt to future data requirements
In order to build a RIM platform that will stand the test of time, you need to focus on data; improving the past, filtering the present, and planning for the future. Despite any marketing, there is no RIM solution on that market that will bring you a 3-5 year competitive or compliance advantage without first approaching this data quality and business process exercise. The good news is that you’re not alone! From the largest to the smallest of our customers, everyone is facing these same challenges.