The EQIPD quality system - Assessment and certification procedures

被引:0
作者
Emmerich, Christoph H. [1 ,3 ,4 ]
Bernard, Rene [2 ]
Steckler, Thomas [5 ]
Bespalov, Anton [1 ,3 ,4 ]
机构
[1] PAASP GmbH, Heidelberg, Germany
[2] Charite Univ Med Berlin, Charitepl 1, D-10117 Berlin, Germany
[3] Free Univ Berlin, Charitepl 1, D-10117 Berlin, Germany
[4] Humboldt Univ, Neurocure Cluster Excellence, Charitepl 1, D-10117 Berlin, Germany
[5] Janssen Pharmaceut NV, Beerse, Belgium
关键词
EQIPD; Quality system; Quality governance; Research integrity; Data quality; Data; Robustness; Reproducibility; Good Research Practice;
D O I
10.1016/j.jneumeth.2023.110053
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
The EQIPD Quality System was designed with the ultimate mission to provide a framework to ensure the quality and integrity of non-regulated preclinical biomedical research. For research quality to be sustained over time, it is crucial to have continuous improvement mechanisms that routinely monitor the research-related processes and enable solutions for identified issues. The present article is focused on these monitoring and assessment procedures that make the EQIPD Quality System a fully functional 'system' (as opposed to a mere collection of guidelines, work instructions and policies). In this context, a critical instrument are the internal and external assessments of the EQIPD Quality System performance described in detail. The assessment procedures emphasize the unique nature of the EQIPD Quality System being user-friendly, flexible and fit-for-purpose. By undergoing the (voluntary) external EQIPD assessment (leading to the EQIPD certification after all EQIPD core requirements have been implemented), a research unit: (i) secures confidence in the quality of data generated, (ii) ensures continuous improvement of research processes, and (iii) obtains an independent seal of quality communicating commitment to best research practices to the research community.
引用
收藏
页数:8
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