Email Review during FDA Inspection

[Lymphatik]

Hello all,

I was wondering if the has the rights to have a look at our emails if we were to use an email as a proof of conformity to one of our procedures?

Thanks

 

[yodon]

If you use email as your objective evidence of compliance then, yes, they would have to look at least at those emails that are applicable. And it might be difficult to keep them from looking at other ones.

I would suggest you reconsider the practice altogether, though. Your evidence of compliance should be managed through document / record control and it would be a tough argument, I believe, to demonstrate proper controls using emails.