Discussion on the Problems and Methods of Animal Laboratory Documents Management from the Perspective of Audit

doi:10.12300/j.issn.1674-5817.2021.114

Laboratory Animal and Comparative Medicine ›› 2022, Vol. 42 ›› Issue (3): 244-247.DOI: 10.12300/j.issn.1674-5817.2021.114

Special Issue: 实验动物设施设备

• Facilities and Management for Laboratory Animals • Previous Articles Next Articles

Discussion on the Problems and Methods of Animal Laboratory Documents Management from the Perspective of Audit

Haiyu LI(), Hufeng XU()

Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China

Received:2021-06-30 Revised:2021-11-30 Online:2022-06-25 Published:2022-07-01
Contact: Hufeng XU

Abstract

Abstract:

Hospital established a good animal experiment platform and a complete set of animal experiment management systems. In good operation, document management is a key element. This paper aimed to improve the management of animal laboratory documents from the perspective of the laboratory accreditation and testing institution accreditation auditor of the China National Accreditation Service for Conformity Assessment (CNAS), and provides a reference for the improvement of the management level of relevant practitioners.

Key words: File management, Animal laboratory, Review, CNAS accreditation

CLC Number:

Q95-33

Haiyu LI, Hufeng XU. Discussion on the Problems and Methods of Animal Laboratory Documents Management from the Perspective of Audit[J]. Laboratory Animal and Comparative Medicine, 2022, 42(3): 244-247.

Figures/Tables 1

References 8

1	刁奇志, 左永艳, 曾强, 等. 医学实验室ISO15189质量管理体系文件的建立及文档的规范管理[J]. 中国医药导报, 2016, 13(32):174-176, 180.
	DIAO Q Z, ZUO Y Y, ZENG Q, et al. Establishing document on IS015189 quality management system of medical laboratory and standard document managment[J]. China Med Her, 2016, 13(32):174-176, 180.
2	肖镜, 王青, 陈旻, 等. 药品检验机构实验室文件控制的研究[J]. 中国卫生质量管理, 2016, 23(2):76-79. DOI:10.13912/j.cnki.chqm.2016.23.2.25 .
	XIAO J, WANG Q, CHEN M, et al. Laboratory document control in pharmaceutical inspection institutions[J]. Chin Health Qual Manag, 2016, 23(2):76-79. DOI:10.13912/ j.cnki.chqm.2016.23.2.25 .
3	李婷婷, 齐红. 文件管理风险评估[J]. 中国食品药品监管, 2006, 145(2):66-69.
	LI T T, QI H. Risk assessment of document management[J]. China Food Drug Administration, 2006, 145(2):66-69.
4	中国合格评定国家认可委员会. 实验动物饲养和使用机构质量和能力认可准则: CNAS-CL06 [S]. 2018-03-01.
	China National Accreditation Committee for Qualification Assessment. Accreditation criteria for the quality and competence of laboratory animal institutions for care and using: CNAS-CL06 [S]. 2018-03-01.
5	欧阳熊妍, 黎美君, 骆展鹏, 等. 质量体系文件管理信息系统的应用体会[J]. 国际检验医学杂志, 2015, 36(15):2285-2285, 2289. DOI:10.3969/j.issn.1673-4130.2015.15.076 .
	OUYANG X Y, LI M J, LUO Z P, et al. Application experience of quality system document management information system[J]. Int J Lab Med, 2015, 36(15): 2285-2285, 2289. DOI:10.3969/j.issn.1673-4130.2015.15.076 .
6	欧阳能良, 黄福达, 兰海丽, 等. ISO15189质量管理体系电子化文件管理模块的建立与应用[J]. 临床检验杂志, 2016, 34(3):219-221. DOI:10.13602/j.cnki.jcls.2016.03.17 .
	OUYANG N L, HUANG F D, LAN H L, et al. Construction and application of management module for electronic documents based on ISO15189 quality management system[J]. Chin J Clin Lab Sci, 2016, 34(3):219-221. DOI:10.13602/j.cnki.jcls.2016.03.17 .
7	中国国家认证认可监督管理委员会. 检验检测机构资质认定能力评价检验检测机构通用要求: RB/T 214—2017 [S]. 2017-10-16.
	Certification and Accreditation Administration of the P. R.C. Competence assessment for inspection body and laboratory mandatory approval-Genaral requirements for inspection body and laboratory: RB/T 214—2017 [S]. 2017-10-16.
8	余海燕. 2010版 GMP中企业文件管理的研究与分析[J]. 健康大视野, 2018(1):95, 94. DOI:10.3969/j.issn.1005-0019.2018.01.062 .
	YU H Y. Research and analysis of enterprise document management in 2010 GMP[J]. Health Perspective, 2018(1):95, 94. DOI:10.3969/j. issn.1005-0019.2018.01.062 .

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Discussion on the Problems and Methods of Animal Laboratory Documents Management from the Perspective of Audit

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