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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 ]
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).
Quality management is focused both on product and service quality and the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines ...
“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 ...
Veeva Systems Inc. is an American cloud-computing company focused on pharmaceutical and life sciences industry applications. Headquartered in Pleasanton, California, it was founded in 2007 by Peter Gassner and Matt Wallach. It operates with software as a service (SaaS) company in the life-science industry. [3]
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.
Experts say vehicle-based attacks are simple for a 'lone wolf' terrorist to plan and execute, and challenging for authorities to prevent.
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