The Quality Assurance audit is a key component of due diligence as well as contractor/supplier assessment, approval and control.Monitoring of manufacturing sites via Quality Assurance audits is also required.This procedure identifies the responsibilities and requirements for performing QA audits of operations related to the items that the firm/function oversees.
This procedure applies to QA audits at wholly owned/joint venture operations, contract manufacturing operations (commercial or clinical), as well as contract analytical laboratories and suppliers of raw materials, components, computer/software, equipment, and services.Corporate QA either conducts such audits, or, if other units conduct them, a various degree of involvement from Corporate QA is required.
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