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Vendor Management
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As the volume and complexity of outsourcing increases, it becomes important to implement a risk-based approach to vendor oversight. Regulatory agencies expect that sponsor companies will ensure qualified personnel are working on their behalf, following GCP-compliant processes, and have adequate controls in place.
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In order to apply a risk-based approach, you have to know your risks. Risks may be based on the complexity of an activity, the regulations...or the vendor's processes.
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Vendor Management
GCC will:
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Perform routine and qualification audits of third party vendors
Assess qualification and training of personnel
Assess QA and Quality Management Systems
Review organizational structure and SOP content
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