Quality Management System (QMS) Update in a Regulated Environment

Abstract

The company XYZ discussed in the study, develops software for clinical research on Multiple Sclerosis (MS). Yet, their QMS (containing SOPs and other important quality documents) implemented in 2020 is out of date and misaligned with current best practices, posing compliance and performance risks. Some of its defined processes are not followed, leading to an oversight of responsibilities, including maintaining the QMS. In light of emergent challenges, this inadequacy highlights the need for an immediate QMS update.