A regulatory-critical application, its interface, and associated local and virtual clients were updated and validated according to GAMP5 within a tight timeframe.
Situation
Within a short period of time, the application, its interface and the associated local and virtual clients were updated and validated to ensure the company's compliance.
Solution
Creation of a detailed project plan and establishment of an efficient project structure. Ongoing project controlling (budget, scope, schedules, resources, quality). Review of relevant documentation and planning, creation and execution of software validation according to GAMP5 (IRA, validation plan and report, IQ, OQ, PQ, SOPs etc.). Coordinate all installation and testing activities.
Impact
The regulatory critical application, its interface and associated local and virtual clients were successfully updated and validated within the tight timeframe. Compliance was ensured without prolonged interruptions to the business process.
Qudits’ role: Project Manager | Validation Manager
Facts & Figures
- 6 months
- 2 consultants