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Case Study – End to End GxP Audits for Global CRO

Research Analysis

Case Study – End to End GxP Audits for Global CRO

Client: Leading Contract Research Organization, North Carolina, USA

ChallengesOur SolutionValue Delivered
1. Scheduling and completing supplier audits on time and across 22 countries

2. Timely follow -up and closure of audit observations

3. Availability of qualified GxP auditors globally		1. Dedicated Project Management Team for efficient communication and coordination with suppliers.

2. Global and Proficient auditor team proficient in GxP practices across various regulatory domains.

3. Effective Audit Tracking for timely closure of audit observations and CAPA through close collaboration with suppliers.

4. RxAMS: RxCloud’s proprietary tool automates audit scheduling, communication, and provides insightful analytics.		1. 100% On -Time Delivery: All audits were completed within the agreed -upon timelines.

2. 100% Compliance with regulatory requirements across different GxP areas.

3. 35% Cost Reduction: Client benefited from cost optimization through our Fixed Price Managed Services Model and reduced travel costs.

4. End -to -End Ownership right from initiation to closure, ensuring a streamlined and accountable approach.
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