(uncountable). 1  The application of a systematic, disciplined, quantifiable approach to the development, operation, and maintenance of software, and the study of these approaches. 2  That is the application of engineering to software.
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Quality Management Systems (QMS) Definition. A QMS system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated QMS system reduces audit time and findings, and a decreases risk of product recalls.