While the opinions about the information model for Regulatory Information Management vary and are subject to many discussions, the one thing most agree on is that promise of regulatory information management (RIM) is that of enabling both compliance and efficiency.
The Complexity of Compliance
Few would dispute the value of an organization being compliant with regulatory requirements. The challenge in Life Sciences is that there is a growing number regulatory requirements from global health authorities and for a company to achieve its market and commercial goals, being able to follow these rules becomes more and more complex. As a result, more and more companies are seeking a means to enabling the capture, management and adherence to global compliance requirements through a single (or integrated) platform designed for this purpose.
The Efficiency Factor
The delicate balancing act that comes with a globally accessible platform designed to enable compliance is ensuring that it improves organizational efficiency at the same time. Those individuals accountable for the information in any RIM solution must feel that it is fit for purpose and making their jobs easier. Without this, the lack of user compliance with system usage will dramatically undermine the organization’s goals of regulatory compliance.
The Promise of Peace of Mind
Accomplishing both compliance and efficiency simultaneously will give organizations tremendous peace of mind, in our opinion. We also believe that both can be achieved by combining connected and holistic process thinking with technology that facilitates this new integrated way of working. We at Cunesoft strive for creating this regulatory peace of mind. If we have sparked your interest, get in contact with us!