A CQMS system is designed to manage all of the documents, activities, tasks, processes, quality events, relationships, audits and training that must be administered and controlled throughout the life of a clinical trial.
The pharmaceutical industry is no exception, with several trade groups (e.g. PhRMA, EFPIA, RQA, etc.)
However, as noted by the Academy of Medical Sciences, there are increasingly complex and bureaucratic legal and ethical frameworks that innovators must work within to develop new medicines for patients.
However, according to FDA as well as other regulatory bodies, "Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement",[3] implying that the same standards that apply to the manufacturing environment should also be applied to the clinical research space, earlier in the lifecycle of an investigational or marketed product.
Accordingly, a CQMS is any system developed to apply these principles to clinical operations within an organization.