Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

The purpose of this Charter is to define the mission, authority, conduct of operations or responsibilities, and membership for the project team.

Duration includes the actual amount of time worked on an activity plus the elapsed time.

Effort is the number of workdays or work hours required to complete a task.

The purpose of the project Change Management Plan is to coordinate changes across the entire project.

A business case document is a formal, written argument intended to convince a decision maker to approve some kind of action. A well-crafted business case explores all feasible approaches to a given problem and enables business owners to select the option that best serves the organization.