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8th Apr 2021, 03:27 PM
#1
Audit Cert as audit evidence?
ICH GCP 8.4.4 specifies an 'Audit Certificate' as evidence of an audit, but does it really need to take the format of a certificate? We're trying to reduce the number of additional, questionably surplus, documents in the QMS. Surely an audit report front page would evidence an audit more appropriately, and could also be included in the appendices of the CSR?
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