Case study 3
CASE STUDY 3 :
Large Pharma Company, USA
Problem Statement
- To implement a strategic audit program for their global CRO and IT service providers.
- Required a robust system to conduct multiple audits across the USA and India, ensuring compliance with global regulatory standards and improving vendor performance..
Our Approach
- Program Design: Developed a comprehensive strategic audit program tailored to the client’s operational and regulatory needs.
- Audit Execution: Conducted 35 audits across USA and India within the agreed timeframe.
- Focused on high-risk areas such as data integrity, GxP compliance, and IT security.
- Impactful Reporting: Delivered detailed audit reports with actionable recommendations to address compliance gaps and enhance vendor performance.
Success Story
- Strengthened the client’s oversight of critical service providers, leading to improved compliance and operational efficiency.
- Client recognized the program’s success by incorporating it as a core element of their global compliance strategy