The Role of Vault RIM in Cross-Functional Processes
Steve Gens, Managing Partner
Gens & Associates
I’m Steve Gens, managing partner of Gens & Associates. Gens & Associates was founded in 2005. We’re a small consultancy serving the life sciences industry. We both do advisory work and well known for our regulatory benchmarks.
The role of a RIM System to make the product change control process efficient is very, very important. It goes hand in hand both with process work, but typically today most organizations will have three or four different regulatory solutions that don’t talk to each other. So by the fact of having one platform, a unified platform, actually takes out a lot at the complexity, and really supports a more efficient process.
Processes are difficult to manage more with the volume, and that’s where the complexity comes. If you’re a mid-tier company or a large, multinational where you might have hundreds of different variations and if it’s done in a non-standard approach, it takes a lot of productivity out of the organization and it increases the compliance risk. If there isn’t clear standards, you run the risk of having compliance issues, especially with inspections or audits. The other thing is when you do have a standardized process, and especially with the complexity of the post- approval changes, it actually increases productivity and efficiency, and we’ve actually proved that out in our research.
Having a unified approach facilitates the connection points, the connection points we look at are the ones to clinical, the product change control, supply release, and in a relationship with QMS. And it’s quite simple is, if you’re working off one platform with the other functional areas, that takes a lot of complexity out as opposed to having four or five different systems that don’t talk to each other. So it’s really an exciting time as far as the investments that a lot of regulatory organizations are gonna be making over the next three to four years to get to the unified approach, and the ability to effectively and efficiently connect up with other functional areas. Because at the end of the day, the regulatory solution is an enterprise asset.
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