Navitas Life Sciences

Point of view - Building a Regulatory Information Enterprise Architecture

Next Generation User Interface to Support Regulatory Information Management – The First in the RIM Enterprise Architecture Series

Selecting the right tool to replace your existing user interface and enable regulatory transparency.

Regulatory Information Management (RIM) has become the focal point across the life sciences industry which is driving a prolific reassessment of processes, systems and ways of doing business that is remarkable given it is not a mandatory requirement. This might be one of the biggest challenges in the pursuit of RIM because it is not mandatory, there are no guidelines, standards, and certainly no proven path to success. However, there are components that are mandatory and have guidelines, standards and tools to enable success, specifically submission management, publishing, licensing, etc. There are emerging requirements that are mandatory as well like IDMP.

These address only a subset of RIM and most solutions address very specific functions, like publishing or submission management and are not integrated. In addition, these tools were not developed with the idea of providing complete transparency and end to end process management across the RIM value chain.

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