摘要
网络和系统基础设施是GLP实验室计算机化系统的基本构架,其验证和管理工作对计算机化系统在GLP机构中的有序运行至关重要。基础设施可在计算机化系统的系统生命周期中被验证,也可独立验证。基础设施验证应全面考虑其特殊方面如基础设施配置、规模和复杂性、硬件和软件以及网络通信等,从而实现以监管为目的的计算机化系统验证。简述了计算机化系统基础设施的验证方法和管理工作特性,以期为建立符合我国GLP原则和法规要求的计算机化系统提供支持和参考。
The network and system infrastructure are the basic framework of computerized system in the GLP laboratories,and their validation and management work is critical to the orderly operation of computerized systems in GLP organizations.The infrastructure can be validated during the system life cycle of a computerized system or independently.The validation of the infrastructure should take into account its specific aspects,such as infrastructure configuration,size and complexity,hardware and software,and network communications in order to achieve the validation of computerized system for regulatory purposes.Infrastructure validation methods,like system life cycle validation also involve the qualification or validation plans,requirementsspecification,qualification or validation reports,and operation and maintenance validation.This paper introduced in detail the feature of validation and management of infrastructure of computerized system so as to provide references for the establishment of computerized system that meet the requirements of GLP principles and regulations in China.
作者
屈哲
霍桂桃
林志
杨艳伟
张頔
李琛
耿兴超
吕建军
QU Zhe;HUO Guitao;LIN Zhi;YANG Yanwei;ZHANG Di;LI Chen;GENG Xingchao;LüJianjun(Beijing Key Laboratory for Safety Evaluation of Drugs,National Center for Safety Evaluation of Drugs,National Institutes for Food and Drug Control,Beijing 100176)
出处
《药物评价研究》
CAS
2020年第2期187-192,共6页
Drug Evaluation Research
基金
“十三五”重大新药创制专项课题“创新药物非临床安全性评价研究关键技术”(2018ZX09201017).
关键词
GLP实验室
计算机化系统
基础设施
验证
管理
GLP laboratories
computerized system
infrastructure
validation
management
