Client: Clinical Research Organization
Service: System Audit
Place : Delhi CRO, India
Clinical Research Organization
Projects
Challenge
- Company’s Management Philosophies towards Quality and Compliance
- Company’s track record in Quality and Compliance
- Company’s Peers in the Industry view
- Employee or Process Errors have occurred since the last few significant change-control
- How Rejections handled
- Regulatory Action against the company
Solution
- Analysis of CRO Team (Has Company Lose
- Process Analysis
- Implementation of CAPA
- Follow up with industry standards and Guidlines
