生态毒理良好实验室机构的计算机化系统数据完整性管理措施探讨  

Discussion on Data Integrity Management Measures of Computerized System in Ecotoxicology Good Laboratory Practice

作　　者：汪丹 范宾 吴孝槐[2] WANG Dan;FAN Bin;WU Xiaohuai(Shanghai TECH.Chemical Industry Testing Co.,Ltd.,Shanghai 200062,China;China National Accreditation Service for Conformity Assessment,Beijing 100062,China)

机构地区：[1]上海化工院检测有限公司,上海200062 [2]中国合格评定国家认可中心,北京100062

出　　处：《肥料与健康》2020年第4期64-69,共6页Fertilizer & Health

基　　金：国家质量监督检验检疫总局科技计划项目(2017IK130)。

摘　　要：研究国际重要数据完整性法规的管理要求,为生态毒理良好实验室(GLP)机构的数据质量和可靠性提供合规性管理思路。通过梳理国际主要数据完整性法规的要求,介绍数据完整性监管现状和数据完整性不足引发的管理风险,讨论数据完整性管理措施的建立、验证、使用和维护方法。导致数据完整性问题的根源包括过于依赖人员操作、使用未正确配置和管理的计算机化系统、未充分审核和管理原始数据与记录,GLP机构应从程序管理、行为管理和技术手段3个方面来建立数据完整性管理措施。计算机化系统验证中融入数据完整性管理不仅是未来监管的重点,也是确保数据符合完整性原则的关键。The management requirements of important international data integrity regulations are studied,with a view to providing compliance management ideas for the data quality and reliability of ecotoxicology GLP(Good Laboratory Practice)institutions.By sorting out the requirements of major international data integrity regulations,the status of data integrity supervision and management risks caused by insufficient data integrity are introduced.The establishment,verification,and use and maintenance methods of data integrity management measures are discussed.The root causes of data integrity problems include over-reliance on personnel operations,use of computer systems that are not properly configured and managed,and insufficient review and management of original data and records.GLP institutions should establish data integrity management measures from three aspects:program management,behavior management and technical means.Integrating data integrity management into computerized system verification is not only the focus of future supervision,but also the key to ensuring that data conforms to the principles of integrity.

关 键 词：实验室管理规范 生态毒理研究 数据完整性 计算机化系统 

分 类 号：X171.5[环境科学与工程—环境科学]