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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 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 ...
Discoveries made using JMP's analytical tools are commonly applied for experimental design. JMP is used in applications such as data mining, Six Sigma, quality control, design of experiments, as well as for research in science, engineering, and social sciences. The software can be purchased in any of five configurations: JMP, JMP Pro, JMP ...
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
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.
EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CRO). Typically, EDC systems provide: a graphical user interface component for data entry
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.
Many disciplines are typically involved in the "8Ds" methodology. The tools used can be found in textbooks and reference materials used by quality assurance professionals. For example, an "Is/Is Not" worksheet is a common tool employed at D2, and Ishikawa, or "fishbone," diagrams and "5-why analysis" are common tools employed at step D4.