Without using any electronic Document Management Software, if we keep all QMS documents on a controlled server using electronic signatures, this is still considered an electronic QMS? I believe the electronic compliance is an FDA requirement; if we are under ISO, is the electronic signature not required?
First off, there's no defined entity of an electronic QMS. There is a QMS and you may choose to manage it as electronic documents and records. There are no FDA requirements for managing a QMS electronically; however, if you do, then the documents and records you manage electronically fall under Part 11.
As
@John Broomfield pointed out, approval is required. You may choose to approve documents through electronic means (e-signature, biometrics). You can manually apply signatures, scan the documents, and still enable access electronically.
If all the QMS documents are kept on a controlled server in an electronic QMS, what QMS software needs to be validated? Since we are not using any particular document management software, does that mean we don't have to validate anything?
Right, if you're not using software, there may not be specific software validation actions required. However, if Part 11 applies, you would want to qualify the system to demonstrate compliance (e.g., system access, protection, etc.). And even if you're not using an electronic document management system, you still probably have backup software that would come into play (since it's likely that's part of the 'protection' considerations).