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  1. #1
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    Feb 2020
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    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?

  2. #2
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    Nov 2011
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    Could you state in your SOPs that the front page of the audit report will be a "Audit Certificate" as defines in ICH E6 8.4.4? It might be best to state exactly what the requirements of the front page are and whether they would be able to describe when and what the audit was to be suitable. Assuming that there is no personal information for which you have not got express consent to have and that there are no details of audit findings on the front page. just an idea

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