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26th May 2021, 05:17 PM
#2
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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