[i]We are implementing some new patches for an existing validated System. I have couple of questions in this regard and will greatly appreciate any suggestions.
-
I am not sure weather to perform complete revalidation (which I think will not be a good option) for the whole system or to do the impact analysis and test only those functionalities/components that are most impacted. Can any one suggest which will be the best approach ?
-
Will it be OK to based the testing on Impact analysis document consider it as a requirement document OR do I need to develop a new requirement document leveraging Impact analysis document.
-
what validation documents/deliveables will be sufficient in this scenario.
Thanks [/i]