During a company-wide merger, Qudits provided GxP validation strategies and CSV expertise to support the digital transformation of logistics processes across all global distribution centers.
Situation
The logistics department was striving to transform from manual to digital processes including management cockpits for product labelling, warehouse management, quality controls, cold chain processes and delivery error management. Compliance with GxP regulatory requirements was required.
Solution
Define validation strategies and consult on strategic application landscape designs from a GxP records, data and validation management perspective. Discuss and agree validation approach with Business, IT, CSV and suppliers. Development and QA review of deliverables over the whole system development life cycle. Execution of Change Management requests for CSV projects.
Impact
Reduction of personnel costs with improvement of processing and allocation of incorrect deliveries. Increased transparency for logistics management. Improvement of validation strategies for new innovative CSV projects to ensure compliance with applicable EU/FDA and global intercompany requirements.
Qudits’ role: Digital Compliance and CSV Expert | Project Lead for Sub-Project "Validation"
Facts & Figures
- 3 years
- all logistic centers & distributors worldwide
- Global GxP standards