Vendor Audits
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CROs
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Review SOPs used to conduct clinical trials to ensure compliance with applicable guidelines and regulations
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Assessment of vendor selection criteria and vendor management
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CRO project team personnel training and qualifications
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Assessment of Quality Management System, Quality Policy and Quality Manual
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Review of CAPA procedures
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Assessment of 483s and other warning letters
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Review of current trial protocols and procedures for on-going studies to ensure regulatory compliance
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Perform qualification audits of prospective 3rd party vendors
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Review organizational structure, SOPs, and Quality Management Systems
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Assess personnel qualifications and training requirements
GCP Audit
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