Regulatory Information Management (RIM) to Improve Efficiency

Overview Challenge Solution Impact

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30%

increase in Efficiency

Challenge

The client needed to design and implement processes as part of a RIM transformation initiative due to fragmented information management processes, informal spreadsheet tracking, and insufficient processes for data exchange with other functional areas, like portfolio and project management, safety and quality.

Solution

Orion managed process design for RIM transformation by defining end-to-end RIM processes that encompassed R&D planning, regulatory requirements, and safety and change controls. Orion provided the following services:

Designed/redesigned and harmonized 15 RIM processes: for e.g., Regulatory, Safety, CMS Change Control, and Correspondence/Commitments
Facilitated workshops and business/data/reporting requirements through analysis sessions
Documented process narratives, business and data requirements
Defined operating model processes for ongoing operations, data quality monitoring, governance, etc.

Impact

Orion improved process efficiency by 30%, ensured end-to-end visibility of data and fine-tuned the process for optimal Veeva configuration.

Improving Efficiency by 30% using Regulatory Information Management (RIM)

Challenge

Solution

Impact

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