Compilation and consideration of the following deliverables is recommended during this phase:
All deliverables of prior phases are managed under version control and updated accordingly.
Components are integrated as planed, validation activities are executed and documented.
Bottom up reporting of validation activities according to the master validation plan is provided in a Master Validation Summary Report.
Still occuring "design/ requirements changes" should be mainly driven through the risk management process with event oriented execution of risk assessment and design change.