Firstly my comments come from mainly the equipment validation perspective. It is usual for larger projects / system to begin with a Validation Plan. This is formally approved and agreed / signed etc. Once this has happened execute as stated. You can structure your documents as you like. Say what you are doing, do what you say. There is no rule. If all is above board and documented and traceable it matters not.
Edited by PaulS on 01-31-07 02:20 PM. Reason for edit: No reason given.