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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 ...
The software makes closed-loop corrective and preventive action procedures (CAPA) possible, which result in faster issue resolution and issue prevention. Feedback loops: Quality management software permits staff to submit feedback or recommendations through centralized software. In turn, this way, managers gather insights from the shop floor ...
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
Enterprise Quality Management Software 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 ...
Software Quality Management (SQM) is a management process that aims to develop and manage the quality of software in such a way so as to best ensure that the product meets the quality standards expected by the customer while also meeting any necessary regulatory and developer requirements, if any.
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
Standalone software used for diagnostic or therapeutic purposes. Software embedded in a medical device (often referred to as "medical device software"). Software that drives a medical device or determines how it is used. Software that acts as an accessory to a medical device. Software used in the design, production, and testing of a medical ...
Within quality management systems (QMS) and information technology (IT) systems, change control is a process—either formal or informal [1] —used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without ...
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