As per the GAMP who will responsible for the preparation of the FDS during validation of ERP software.

if Vendor is not providing any documents like FDS and all, then what is the procedure for FDS preparation

FDS: Functional Design Specification


If the vendor is not providing a Functional Design Specification…Then what are you testing against?

In case the vendor is not providing the FSD, I think you should ask them for any or all of the document

  • Design Specs (DS),
  • current release notes
  • User guide
  • Any executed test scripts that they have
  • Requirement document (they should have this).

When you get the above document, ask them for the demo of the application and work with the vendor to complete FSD.