Early on in the initiation and planning phases it is important to understand GMP requirements and how they relate to the project. For example, if your company is now developing a combination device and they have not before, they will be required to meet a whole additional set of standards. These quality system updates will need to be factored into the project planning. During project execution you will be making sure all of the GMP requirements are met for the project. Submissions to regulatory agencies will be required and they will be auditing the company to make sure the requirements were properly carried out. During the controlling and monitoring phase you are observing the process after project implementation to identify problems and risks. This is where a good quality system is very important. If you did a good job with the project management process, there will be quality checks set up throughout the process so those things can be identified early and quickly.