I am currently working on a project where the user group purchased the validation package from a 3rd party vendor. In doing a pre-execution review of the test scripts, there are a few things that I know isn’t the right way to handle them, but I also know that the user group will not blindly accept my “we need to make sure that we cover X, Y and Z” and I need to prove it.
X would be - tests steps that start with “Verify or modify the following” and you are changing test configuration within a test
Y would be - test steps that have multiple expected results - if you make a change you will get this, if you didn’t change anything you will get this (see X above)
Z would be - I have granted access to a user that they are allowed to access a new site within the system, however it is never tested that they can actually access it, or that if they don’t have access to a site they are not able to access that sight.
I was “brought up in validation” going with - 1 action 1 expected result, systems should be configured before testing starts and you are to test the configuration that you are going to be using and not changing it on the fly, and if you state that you have a role that should be able to do something you test that someone without that role cannot do the task.
I need to find a quick - none fda/gamp-ese that will help support me.
any ideas? adivce?