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Quality assurance: Importance of systems and standard operating procedures
It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to...
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Formato: | Texto |
Lenguaje: | English |
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Medknow Publications
2011
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3088954/ https://www.ncbi.nlm.nih.gov/pubmed/21584180 http://dx.doi.org/10.4103/2229-3485.76288 |
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author | Manghani, Kishu |
author_facet | Manghani, Kishu |
author_sort | Manghani, Kishu |
collection | PubMed |
description | It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company. |
format | Text |
id | pubmed-3088954 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | Medknow Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-30889542011-05-16 Quality assurance: Importance of systems and standard operating procedures Manghani, Kishu Perspect Clin Res Quality It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company. Medknow Publications 2011 /pmc/articles/PMC3088954/ /pubmed/21584180 http://dx.doi.org/10.4103/2229-3485.76288 Text en © Perspectives in Clinical Research http://creativecommons.org/licenses/by/2.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Quality Manghani, Kishu Quality assurance: Importance of systems and standard operating procedures |
title | Quality assurance: Importance of systems and standard operating procedures |
title_full | Quality assurance: Importance of systems and standard operating procedures |
title_fullStr | Quality assurance: Importance of systems and standard operating procedures |
title_full_unstemmed | Quality assurance: Importance of systems and standard operating procedures |
title_short | Quality assurance: Importance of systems and standard operating procedures |
title_sort | quality assurance: importance of systems and standard operating procedures |
topic | Quality |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3088954/ https://www.ncbi.nlm.nih.gov/pubmed/21584180 http://dx.doi.org/10.4103/2229-3485.76288 |
work_keys_str_mv | AT manghanikishu qualityassuranceimportanceofsystemsandstandardoperatingprocedures |