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The seven basic tools of quality are a fixed set of visual exercises identified as being most helpful in troubleshooting issues related to quality. [1] They are called basic because they are suitable for people with little formal training in statistics and because they can be used to solve the vast majority of quality-related issues.
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 ...
In August, 2009, Health Canada which is responsible for regulating the advertising, manufacturing and sale of medical devices in Canada issued a notice confirming that patient management software is a medical device and is subject to the Medical Devices Regulations and the Food and Drugs Act.
Quality management software centralizes the storage of these documents. Regulatory compliance: To decrease compliance risks, quality management software is used within companies to make sure they comply with ISO, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures ...
The international standard ISO 9000:2015 (Title: Quality management systems - fundamentals and vocabulary) defines the term in chapter 3.5.3 as a "set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives".
The intersection of technology and quality management software prompted the emergence of a new software category: Enterprise Quality Management Software (EQMS). EQMS is a platform for cross-functional communication and collaboration that centralizes, standardizes, and streamlines quality management data from across the value chain.
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 provide the safe and effective delivery of medical care, virtually all clinical staff use a number of front-line health informatics tools in their day-to-day operations. The need for standardization and refined development of these tools is underscored by the HITECH Act and other efforts to develop electronic medical records .