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GLP实验室计算机化系统的质量保证关键点 被引量:2

Key Points of Quality Assurance in the Computerized System of GLP Laboratory
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摘要 在GLP背景下,计算机系统使用存在着诸多问题。从应用实践来说,合理构建系统,优化系统的安全性,对提高系统工作效率,避免数据损毁,提升系统整体的安全性,有着重要的意义。对GLP实验室计算机化系统的质量保证关键点进行论述,并总结把控要点。 In the context of GLP,there are many problems in the use of computer systems.From the application practice,it is important to construct the system reasonably and optimize the security of the system to improve the efficiency of the system,avoid data corruption and improve the overall security of the system.The meaning.Now,for the key points of quality assurance of the computerized system of GLP laboratory,we will make a simple discussion,summarize the key points of control.
作者 高颖 李昌辉 Gao Ying;Li Chang-hui
出处 《化工设计通讯》 CAS 2019年第2期245-245,共1页 Chemical Engineering Design Communications
关键词 GLP 实验室 计算机化系统 质保关键点 GLP laboratory computerized system key point of quality assurance
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  • 1McDowall RD. Computer (in) security- 1: logical security [J].Qual Assurance J, 2000, 4 (4): 197-205.
  • 2USFDA 21 CFR 11. Electronic records and electronic signa tures final rule [J]. Fed Regist, 1997, 64:13430-13466.
  • 3国家质量监督检验检疫总局和中国同家标准化管理委员会.《良好实验室规范要求》第6部分:良好实验室规范原则在计算机化的系统中的应用[S].国标GBT22275.6,2008.
  • 4US FDA Guidance for Industry: 21 CFR Part 11: Electronic Records and Electronic Signatures: Scope and Application[S].Final August 2003.
  • 5US FDA - Guidance for Industry: Computerized Systems used in clinical trials [S].revision 1 draft September 2004.
  • 6Concerning the processing of personal data and the protec tionof privacy in the electronic communications sector (Direc rive on privaeyand electronic communications) [Z] Direc tive 2002/58 of the European Parliament and of the council of 12July 2002,.

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