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Challenge

The client, a global pharmaceutical company, struggled with data migration from a previous RIM transformation initiative and wanted to implement a new RIM process to ensure quality data. After facing issues with multiple data remediations from prior RIM implementations, the client was looking for a more efficient alternative.

Solution

The Orion team defined different strategies for data quality and active migration of all regulatory submissions. We created active mature products to migrate limited submission chronology. Additionally, the team recommended data ownership based on functional area, domain-based data stewardship, formed operations teams, performed weekly compliance checks, and made frequent adjustments to the process as needed. Strong change management encouraged user adoption to drive data quality.

Impact

Our work resulted in better metrics for management reporting, streamlined decision-making, a reduction in compliance issues across RIM process areas, and greater user adoption of new processes and systems.