Today we are proud to announce another milestone for our organization. Being ISO certified means that our QMS drives the three key principles of ISO 9001.
Building Critical to Quality Trees helps you to translate critical study needs and quality drivers into measurable outcomes and processes. Initially, this Lean Six Sigma approach serves as a business tool based on customer needs. Still, it is a helpful method of implementing Quality by Design in clinical research.
Within the bounds of risk-based quality management, the utilization of predefined Quality Tolerance Limits (QTLs) is a way to control quality and risk in clinical trials. QTLs identify systematic risks to patients and data integrity at the study level. We've listed the 7 most commonly used QTLs that are applicable to most trials.