Overview
In clinical research, meticulous vendor management ensures compliance with regulatory standards and data integrity. ACL Digital Life Sciences assisted a mid-sized Contract Research Organization (CRO) when it faced a critical challenge. Several vendor re-qualifications were not completed as planned, posing a significant risk of non-compliance with regulatory requirements (ICH-GCP, FDA, EMA). With an impending sponsor audit, the CRO sought swift resolution to mitigate risks and uphold regulatory obligations.
Challenges
Delayed vendor re-qualifications jeopardizing data integrity and regulatory compliance
Impending sponsor audit necessitating swift resolution to demonstrate preparedness
Need for a practical solution to address delays and mitigate compliance risks effectively
Benefits
- Enhanced Compliance: The risk-based re-qualification approach ensured adherence to regulatory requirements, mitigating the risk of non-compliance during Sponsor Audits
- Improved Risk Management: Prioritizing critical vendors for re-qualification focused resources on the areas of highest risk, strengthening overall clinical trial integrity
- Streamlined Processes: The updated re-qualification process with clear prioritization facilitated efficient vendor management
- Preparedness for Audit: The CRO was well-equipped to address potential audit findings with a comprehensive deviation list and corrective action plan
