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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 ]
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.
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 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".
“Pharma is a data-driven business,” explains Hussein Jaafar, a senior consultant at Lifescience Dynamics, who has largely led the charge on the team’s adoption of artificial intelligence ...
Total quality management (TQM) 1985: Quality movement originating in the United States Department of Defense that uses (in part) the techniques of statistical quality control to drive continuous organizational improvement [12] Six Sigma (6σ) 1986: Statistical quality control applied to business strategy; [13] originated by Motorola: Lean Six ...
The products that are the subject of the GxP are expected to be Traceability: the ability to reconstruct the development history of a drug or medical device. Accountability: the ability to resolve who has contributed what to the development and when. GxPs require that a Quality System be established, implemented, documented, and maintained.