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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 ...
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). [1]
“A system is defined as a network of interdependent components that work together to try to accomplish a specific aim.” Source: Nelson, E.C., Batalden, P.B., Godfrey, M.M. (2007) Quality by Design. A Clinical Microsystems Approach. John Wiley & Sons Inc. (p. 230) “A system is an integrated series of parts with a clearly defined goal.”
The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure
ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization's Technical Committee 212 (ISO/TC 212).
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.
Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control, and quality improvement. [1] Quality management is focused both on product and service quality and the means to achieve it.
Additionally, quality management system requirements for manufacturing a software medical device, as is the case with any medical device, are described in the U.S. Quality Systems Regulation [25] of the FDA and also in ISO 13485:2003.