Biopharmaceutical Company Veeva Vault RIM Implementation

Challenge

In preparation for a significant BLA submission, a late-stage biopharmaceutical company identified the need to optimize document management and improve process transparency. The company, reliant on manual SharePoint processes, opted for Veeva Vault RIM to facilitate this change. Their strategy was to capitalize on Veeva’s out-of-the-box configurations to ease the implementation and ongoing operations, all within a validated environment. The work included migrating all legacy information into the new system.

Approach

Osprey supported the client with a team of experts to lead and assist with subject matter expertise in many project areas including:

  • System implementation and migration expertise helped leadership understand the timelines and plan a successful rollout.
  • Leading role-based system training development and delivery in collaboration with functional area leadership to ensure training aligned with business processes.
  • Managing validation efforts, ensuring compliance with industry standards and company processes.
  • In addition, Osprey was able to its internal skills to provide timely support for business process development and SOPs, allowing project tasks to be completed on time in conjunction with pivotal business-as-usual tasks.

Solution

Veeva Vault RIM was successfully implemented as the client’s go-to document management and tracking system for Regulatory Submissions.

Comprehensive training was provided, and system roles were carefully tailored to align with each user’s role in the submission process, ensuring a seamless and predictable outcome.

 

 

Veeva Vault RIM is now system of record for all past and future submissions, including the client’s upcoming BLA submission.

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