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Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...
Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality ...
Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...
Quality management uses quality assurance and control of processes as well as products to achieve more consistent quality. What a customer wants and is willing to pay for it determines quality. It is a written or unwritten commitment to a known or unknown consumer in the market.
Through the implementation of established and routine quality assurance programs, two primary functions are fulfilled: the determination of quality, and the control of quality. By monitoring the accuracy and precision of results, the quality assurance program should increase confidence in the reliability of the reported analytical results ...
With this framework – according to Hinz [2] – the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the time of conducting phase-2 clinical trials.
Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies. [1] [2] Depending on the jurisdiction, different education and certification requirements may be necessary, although not usually required, to practice as a clinical research associate.
QA/QC is the combination of quality assurance, the process or set of processes used to measure and assure the quality of a product, and quality control, the process of ensuring products and services meet consumer expectations.