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Case Study

Implementation of the LifeSphere Regulatory Management System (LS RIMS)

Five separate regulatory applications were consolidated into the LifeSphere RIMS; Qudits managed testing, incident handling, and validation support across 43 testers.

Situation

Implementation of a new application led to new processes that had to be introduced, trained, and supported. Due to various interfaces, the data migration beforehand was a challenge. Various stakeholders across different areas had to be coordinated and supported in testing.

Solution

Creation of a Test Matrix to effectively plan resource involvement and to best track the activities running in parallel. Setup of Incident Handling process. Execution of Classroom Sessions, testing support, Incident Management and status reporting.

Impact

Five different applications were replaced by one source combining the data, giving a full overview of status for documentation to authorities. More efficient structures implemented and challenges with the existing applications solved, leading to higher quality and more efficient compliance.

Qudits’ role: Test Manager | Incident Manager | Validation Support

Facts & Figures

  • 1 new central application
  • 5 interfaces
  • 43 testers
  • 875 test steps
Related service: Quality & Compliance