The 3 Pillars Of A Life Science Quality Management System

As companies progress through clinical development towards regulatory submission , if a quality management system and process is not laid out from the beginning, they face significant risks. Mainly, they may fail to get company products recommended if they do not comply with the requirements of regulatory authorities that are necessary for approval.

What is the most efficient solution? How can senior management, clinical, regulatory, and discovery teams focus on what they need to execute while building quality into the process? The answer is implementing a quality management system from the outset, or using a third - party provider to develop and implement a system. By doing so, companies can ensure compliance, and confirm that the quality management system continues to be followed over time . Anybody who has been through a n FDA regulatory inspection knows that if a quality system is not in place, the likelihood of product approval may be in serious jeopardy — even if the product in question has been proven to be safe and clinically efficacious. We have discovered that each quality management system is made up of three pillars of technology: a Document Management System (DMS) , a Learning Management System (LMS) , and once clinical trials begin, an electronic Trial Master File (eTMF) .