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.

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.

The milestone list is a basic table of the milestone descriptions, planned completion dates, whether they’re mandatory or optional milestones, and how the completion of the milestone will be verified. This document provides an easy reference to all project stakeholders on what milestones are included in the project and when they will occur.