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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 leading to new required processes which need to be implemented, trained and supported. Due to various interfaces the data migration beforehand has been a challenge. Various stakeholders over different areas had to be coordinated and supported in testing.

Solution

Creation of a Test Matrix to effectively plan the resource involvement and to best track the parallel ongoing activities. 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 full overview of the 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: Qualität & Compliance