Electronic signatures FDA CFR 820

JesseE

Registered
Hi there,
I understand that we now to have make sure all finalised SOPs have to be digitally signed off but I am wondering how to go about this. Can you just use any generic digital signing company (eg, adobe) and let the FDA know or is there only one kind of digital signature you can use to be compliant to FDA CFR 820?
Any help greatly appreciated.
Thank you
 

Tidge

Trusted Information Resource
Hi there,
I understand that we now to have make sure all finalised SOPs have to be digitally signed off but I am wondering how to go about this. Can you just use any generic digital signing company (eg, adobe) and let the FDA know or is there only one kind of digital signature you can use to be compliant to FDA CFR 820?

When you notify the FDA that you intend to use Electronic Signatures, you don't have to specify HOW or WHERE you will be using them. Many places use not just both wet and electronic signatures, but also multiple different methods of electronic signatures.
 
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