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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 management software centralizes the storage of these documents. Regulatory compliance: To decrease compliance risks, quality management software is used within companies to make sure they comply with ISO, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures ...
The concept of validation was first developed for equipment and processes and derived from the engineering practices used in delivery of large pieces of equipment that would be manufactured, tested, delivered and accepted according to a contract [2] The use of validation spread to other areas of industry after several large-scale problems ...
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).
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 ...
The ISO 9000 family is a set of international standards for quality management systems.It was developed in March 1987 by International Organization for Standardization.The goal of it is to help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. [1]
A framework for gathering and analyzing data of final product quality and process consistency. Analysis should include source materials consistency and manufacturing equipment condition; and data should be collected in a format that allows for long-term trend analysis as well as intra-production quality analysis.
Total quality management (TQM) 1985: Quality movement originating in the United States Department of Defense that uses (in part) the techniques of statistical quality control to drive continuous organizational improvement [12] Six Sigma (6σ) 1986: Statistical quality control applied to business strategy; [13] originated by Motorola: Lean Six ...