Within a short period with a hard deadline, a regulatory-critical application was updated and fully validated according to GAMP5 to ensure continued compliance.
Situation
Within a short period of time with a hard deadline, the application had to be updated and validated to ensure the company stays compliant.
Solution
Creation of a detailed project plan and setup of project governance. Ongoing project controlling (budget, scope, timelines, resources, quality). Review of the life cycle documentation as well as the planning, creation and execution of the software validation according to GAMP5 (IRA, validation plan and report, IQ, OQ, PQ etc.). Coordination of all installation and testing activities.
Impact
The critical regulatory application was successfully updated and validated within the tight timelines. By introducing more efficient structures, keeping close tracking of all activities and solving the challenges, compliance was ensured without longer interruptions of the business process.
Qudits’ role: Project Manager | Validation Manager
Facts & Figures
- 4 months
- 2 consultants