A regulatory-critical database was migrated from Oracle 11 to MS SQL and validated per GAMP5 within a short timeframe to ensure continued compliance.
Situation
Within a short period of time, the database and associated data were migrated and validated to ensure the company was compliant.
Solution
Creation of a detailed project plan and efficient project structure. Ongoing project controlling. Review of relevant documentation and planning, creation and execution of software validation according to GAMP5 (IQ, MQ, PQ). Ensure correctness and completeness of migrated data through specified test steps.
Impact
The regulatory critical database was successfully migrated and validated within the tight timeframe. Compliance ensured without prolonged interruptions to the business process.
Qudits’ role: Project Manager | Validation Manager
Facts & Figures
- 6 months
- 2 consultants