摘要
GLP机构中使用的计算机化系统必须符合良好实验室规范的要求,为确保实验数据真实、安全、可靠,不但要对计算机化系统验证开展生命周期管理,而且要对系统生命周期活动中涉及的人员的资质、职责和培训提出要求,确保从计算机化系统的概念、需求、设计、开发、发布、操作使用及维护,直至系统退役及存档的所有活动均符合GLP要求。简要介绍计算机化系统验证生命周期的概念、内容及主要任务,计算机化系统验证生命周期各阶段的需求及特殊的考虑要点,以期为我国GLP机构的计算机化系统开发、验证提供一定参考,进一步提高计算机化系统的使用效率,确保数据的准确性和可靠性,以加快我国GLP机构临床前药物安全性评价数据的国际认可。
Computerized systems used in GLP facilities are required to comply with regulations of good laboratory practice.To ensure the authentic,safe and reliable experimental data,it is not only necessary to carry out the management of the life cycle of computerized system validation,but also to make requirements for the qualifications,responsibilities and training of personnel involved in the system life cycle in order to ensure the concept,requirements,design,development,release,operation and maintenance,until retirement and archiving of the computerized system are in compliance with the requirements of GLP.This paper briefly introduces the concept,content and main tasks of the life cycle of computerized system,the requirements and special considerations of each stage of the life cycle of computerized system,in order to provide some references for the development and validation of computerized system in GLP facilities in China,to further improve the efficiency of computerized system and to ensure the accuracy and reliability of experimental data,and to accelerate the international mutual acceptance of experimental data from GLP facilities for preclinical safety evaluation of drugs in China.
作者
霍桂桃
屈哲
张曦
林志
张頔
杨艳伟
李琛
吕建军
HUO Guitao;QU Zhe;ZHANG Xi;LIN Zhi;ZHANG Di;YANG Yanwei;LI Chen;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,China)
出处
《药物评价研究》
CAS
2020年第2期179-186,共8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).
