This document outlines the change control process and responsibilities of different parties. The change requester notifies quality assurance of any change and ensures it is not implemented until approved. The requester also coordinates approved changes. Area experts must assess if changes impact their areas. Quality assurance owns the change control system, assigns numbers, tracks changes, and approves that changes do not duplicate or adversely impact other areas after understanding the scope. They also ensure regulatory compliance and GMP/GLP conditions are maintained.