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Transforming Compliance and user experience with Veeva RIM for multinational medical devices and healthcare company

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Overview.

Disconnected and unstructured regulatory systems lead to highly manual processes, lack of visibility, and inconsistent compliance. To address these challenges, our client who is a leader in healthcare wanted to implement a multi-platform consolidation program to migrate to a single, unified regulatory system. Leveraging Coforge Data & Analytics proficiency allowed the client to standardize processes, increase visibility, and gain better control over regulatory content and workflows globally.:

Challenges

  • Replacing disparate regulatory content repositories with a harmonized platform for continuous compliance.
  • Addressing pain points caused by disconnected regulatory data, aiming to enhance user experience, efficiency, scalability, and productivity.
  • Meeting the diverse global stakeholder needs with a unified platform for streamlined process and content management.

Solution

  • Replaced disparate repositories with Veeva Vault, enhancing user experience, efficiency, scalability, and productivity.
  • Created a data inventory, assessed data quality, conducted user interviews, and reviewed regulatory requirements using Veeva RIM for compliance support
  • Mapped existing data to the new structure, cleaned and transformed data to match the schema of Veeva RIM.
  • Implemented validation checks, conducted User Acceptance Testing (UAT) with stakeholders, and promptly addressed issues within the Veeva RIM environment.
  • Met global stakeholder needs with a unified, streamlined platform for continuous compliance, leveraging Veeva’s comprehensive suite for regulatory content management.
  • Developed a migration strategy, established a timeline, allocated resources, conducted pilot testing, executed full-scale migration, ensured system integration, and provided post-migration support, all within the Veeva RIM framework.

The Impact

  • Improved Compliance by integrating disparate content management repositories.
  • Streamlined Operations by harmonizing the platform to gain consistency and efficiency.
  • Reduce Complexity for global business processes.
  • Benchmarked quality to match up to the industry peers.

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