Module 12 2019

Why Look at RIM as a Focus?

Companies with a common RIM capability (n = 30)…

1) Are 3.5 times more likely to realize business benefits than their disparate capability counterparts; especially in better process integration, reduced time to Health Authority submission and higher user productivity 2) Have a stronger focus on data quality (2.5 times more likely to have high quality data) and right the first time with the ability to report on that data in hours or days

A common RIM capability provides higher business benefits and value

Core Findings

3) Are better aligned organizationally to support the RIM program

4) Are more progressive with implementing emerging technologies

5) Were 18% (on average) more efficient in capabilities typically included in a RIM program; significant difference in product registration, submission production, and submission document management efficiency were clear

Reference: Gens & Associates: World Class Regulatory InformationManagement Whitepaper; Connections to Supply Release, Product change and QMS. 2018 Fall Edition

The Organisation for Professionals in Regulatory Affairs 12