Achieving inspection readiness means that during all stages of a clinical trial, a regulatory inspector would be able to walk into the building and reconstruct the trial using only the documents and metadata present in the trial master file (TMF). Although the concept of an inspection-ready TMF may be simply described, inspection readiness is not easily achieved. The failure to achieve an inspection-ready TMF continues to be an area of growing risk for the clinical research industry.
This article will address the expected roles of quality control and quality assurance, how these roles are related and how they are different, and how they must work together to create a sound quality management system (QMS).
The QC lab is often seen as outside of the pharmaceutical production process, and, as a result, opportunities for improved efficiency and operational excellence are missed. A major source of complexity and poor utilization of resources is often lab throughput time — the time between the arrival of a test sample in the lab, completion of testing, and release of the data.
Over the last several months, we’ve heard of far too many incidents of sexual harassment or worse coming to light. In the event you’re not familiar with the terms, #MeToo is a hashtag used in social media to demonstrate the prevalence of sexual assault and harassment. It went viral as victims started to post their own stories, showing how widespread the problem actually is. Founded by Hollywood celebrities in response to several high-profile sexual harassment and assault cases in the entertainment industry, the Time’s Up initiative champions change in these behaviors and works to establish fair treatment for all.