eTMF During Inspection

[Mariz Hanna]

Hi All,
we are currently using Veeva eTMF system during an inspections what is the best industry practice do you assign the auditor role in the system and have the inspector access the system or print the document from system and provide it to the auditor in paper format?

[Eldin Rammell]

Hi Mariz,

Different inspectors will have their own preferences but usually they require direct access to the system. I recommend getting this clarified before the inspection actually happens ie. in your pre-inspection communications.

Kind regards,
Eldin.

[Mariz Hanna]

Thank you Eldin

[ksarchila]

Hi Mariz
We also use Veeva eTMF and have created a separate user profile for auditors. This requires of course a small training but they have access to see all final documents and they can also review our audit trail. I think it’s important to ask the inspector what they would prefer but in my experience, most of they would like to see the documents in the system.

[Mariz Hanna]

Thank you Ksarchila.

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