A C D E F G H I L P Q V
Qm Qu

QMSR

The Quality Management System Regulation (QMSR) is the U.S. regulation of the quality management system for medical devices – 21 CFR Part 820, effective February 2, 2026. It replaces the previous Quality System Regulation by directly incorporating the requirements of…
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Qualification

Qualification is the act of demonstration for the stable, stationary object – plant, equipment, and piping in GMP manufacturing, and likewise the IT infrastructure (frame of reference: EU GMP Annex 15; Annex 11, principle: validate the application, qualify the IT…
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Quality

The term quality is derived from the Latin word “qualitas”, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent characteristics of an object meets requirements. Inherent means…
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Quality Management

Quality Management (QM) refers to all organizational measures that relate to the structure of the organization and the efficient execution of processes at various levels of the company. With consistent implementation, quality management enables the continuous improvement of corporate culture,…
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