We have been filing the signed Document Release Notice in a floder. Now I have a space in our server for QA Documents. Is is OK for me to scan these signed form and save it in the server and dispose the signed copy. Or I need to retain the signed copies in a folder. Please advice.

We have been filing the signed Document Release Notice in a floder. Now I have a space in our server for QA Documents. Is is OK for me to scan these signed form and save it in the server and dispose the signed copy. Or I need to retain the signed copies in a folder. Please advice.

Welcome to the Cove.

There is no requirement to retain a signed copy. Having said that, check that your own procedure doesn't require it. You may have to change your procedure. If your system allows for electronic copies, there is no reason to scan the signed document. You should determine how your system ensures review and approval, state it in your procedure then control the electronic copy. Don't overburden yourself by requiring a signature and a scanned copy.

Dave

If it matters, FDA rules arguably are different. We've recently had an audit by one of our largest OEM customers. Per their interpretation of FDA requirements, to which they audited, the only acceptable record for required documentation signatures is a retained handwritten original signature in ink on the original paper document. That's in the context of our not being not Part 11 compliant (i.e. electronic signatures) at this point.