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Vendor Audits

  • CROs

    • Review SOPs used to conduct clinical trials to ensure compliance with applicable guidelines and regulations ​

    • Assessment of vendor selection criteria and vendor management 

  • CRO project team personnel training and qualifications ​

  • Assessment of Quality Management System, Quality Policy and Quality Manual 

  • Review of CAPA procedures

  • Assessment of 483s and other warning letters

  • Review of current trial protocols and procedures for on-going studies to ensure regulatory compliance 

  • Perform qualification audits of prospective 3rd party vendors

  • Review organizational structure, SOPs, and Quality Management Systems

  • Assess personnel qualifications and training requirements 




GCP Audit

Good Clinical Consultants - GCP Audits, QMS

GCC will: 

Review SOPs for compliance within applicable regulations and guidelines and, if needed, create entirely new SOPs. 

Review computer systems procedures and documentation, including those for security, back-up, and recovery 

Review QA unit reporting structure, auditing practices, and CAPA procedures

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