Gens and Associates Blog

Our latest research demonstrates that a continuous improvement programme (CIP) has a measurable effect on your regulatory information management (RIM) programme performance over time.

There are growing efforts to improve the connection between regulatory information management (RIM) systems and enterprise resource management (ERP) solutions used for product change control and supply release. We know that improving data management and connections to other functional areas (clinical, safety/PV etc.) is a priority for companies.

Over the years in developing the Gens and Associates surveys we’ve learned a great deal about developments in regulatory information management (RIM), including what companies are doing and thinking, what they’re concerned about, what they’re planning, and the effectiveness and efficiencies gained from RIM.

In my last blog, I shared with you some of the findings from our recently completed 2018 World Class Regulatory Information Management; Connections to QMS, Supply Release, and Product Change Survey. In particular, I spoke about the progress made with RIM investments and how these are – or aren’t – impacting efficiency and data quality.

We recently completed our 2018 World Class Regulatory Information Management; Connections to QMS, Supply Release, and Product Change Survey in April of this year. This was our 33rd benchmark and fourth focus on Regulatory Information Management (RIM). There were many significant findings, but I will focus on just a couple in this blog.

Over the past decade, outsourcing has become an intrinsic part of how life sciences companies operate. Since we began tracking outsourcing in 2007, we’ve seen constant growth to the point that in our 2014 survey analyses we declared that outsourcing is no longer a growing trend, but in fact common practice.

With the release of our 2016 white paper, Pursuing World Class Regulatory Information Management (RIM); Strategy, Measures and Priorities, I wanted to delve into some interesting findings with regards to medical devices companies.

As we continue the analysis from the 2016 Gens and Associates World Class Regulatory Information Management (WCRIM) survey of 54 companies, there are some key findings that provide interesting insights on industry trends and what companies want to achieve with their regulatory information management (RIM) solutions and processes.