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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 ...
Quality engineering is the discipline of engineering concerned with the principles and practice of product and service quality assurance and control. [1] In software development, it is the management, development, operation and maintenance of IT systems and enterprise architectures with high quality standard.
It is still difficult for systems designers to build machines that allow finished products to be inspected easily. To do so requires an understanding of the product being manufactured and how inspection tasks can improve the quality control process. [3] Inspection can represent a significant percentage of an existing product's manufacturing cost.
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 control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". [1] This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): [2] [3]
"Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and ...
Quality management software can be integrated with manufacturing execution systems (MES). A MES is a complete, dynamic software system for monitoring, tracking, documenting, and controlling the manufacturing process from raw materials to final products. [14] When combined with QMS, these systems: ensure compliance; enable quality programs ...
Risk assessment procedure. When quality control of TEMPs is considered, a risk assessment needs to be conducted. A risk is defined as a "potentially unfavourable effect that can be attributed to the clinical use of advanced therapy medicinal products (ATMPs) and is of concern to the patient and/or to other populations (e.g. caregivers and off-spring)". [3]