Qudits executed a systematic data quality self-inspection in Veeva Vault RIM, covering 5 regulatory focus areas with 68 automated checks and reporting results to the Global Regulatory Data Council.
Situation
High regulatory demands on data integrity and quality in Veeva Vault RIM. Heterogeneous master data, lack of transparency on data status, and the need to prepare for internal and external inspections.
Solution
Development of a Self-Inspection framework focusing on five core data quality dimensions: completeness, consistency, accuracy, timeliness, and correctness. Execution of automated analyses (Power BI, Python), manual sample validation, and reporting of results to the Global Regulatory Data Council.
Impact
Systematic analysis and assessment of data quality in Veeva Vault RIM across five regulatory focus areas (Registration & Registered Details, Renewals, Safety Aggregate Reports, Labeling, and Commitments). Identification of concrete improvement measures and definition of sustainable Data Quality KPIs to ensure audit and inspection readiness.
Qudits’ role: Lead & execution of the Data Quality Assessment & Self-Inspection
Facts & Figures
- 5 focus areas (Labeling, Commitments, Renewals, Registrations, Safety Reports)
- 68 Data Quality Checks conducted
- 68 Dashboards & reports developed
- 4 months project duration