Audit Plan, Report, Evidence of Execution and Certificates

[Jane Marie Johnson]

We currently file
Audit Plan in 01.01.03 (Quality Plan section)
Audit Certificates in 01.01.14 (Audit Certificates section)

Where do others file the detailed audit reports, worksheets, checklists etc. that are deemed confidential and not required to be provided to a Regulatory auditor? Do you create a separate confidential folder within one of the above areas? Include a NTF/Pointer as to where the documents are located outside of the TMF? Other?

All suggestions and ideas are much appreciated!

[Allison Grosik]

I commonly see audit reports filed in the Company’s internal quality system. You can specify the filing location on the Study TMF Plan/EDL rather than generating a NTF.

Best regards,
Allison Grosik
LMK Clinical Research Consulting

[Janna Gonzalez]

Hi Allison,

Where do you file General documents?
They are not Study Level or Site level documents?
For Ex.
General Product Information
Study Cancellation
Study On Hold
Suspended Study
thanks,
Janna

[Author]

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