Validation of computerized system in facilities for preclinical safety evaluation of drugs
10.7501/j.issn.1674-6376.2017.11.001
- VernacularTitle:药物临床前安全评价机构计算机化系统的验证
- Author:
tao Gui HUO
1
;
Xi ZHANG
;
jun Jian LV
;
Chen LI
;
Zhe QU
;
Zhi LIN
;
gang Zuo LI
;
chao Xing GENG
;
Yan HUO
;
Xue WANG
Author Information
1. 中国食品药品检定研究院国家药物安全评价监测中心、药物非临床安全评价研究北京市重点实验室
- Keywords:
drug;
preclinical safety evaluation;
computerized system;
validation
- From:
Drug Evaluation Research
2017;40(11):1525-1530
- CountryChina
- Language:Chinese
-
Abstract:
Computerized system has been played an increasingly important role in preclinical safety evaluation of drugs and has been used directly or indirectly for data acquisition,processing,reporting as well as raw data storage.However,the computerized system has not been widely used in facilities for preclinical safety evaluation of drugs or only some functions of modules of computerized system have been used.Based on the current application status of the computerized system in the facilities for preclinical safety evaluation of drugs in China,this paper briefly introduced the following aspects about validation of computerized system,such as GLP regulatory requirements of validation of the computerized system,validation process of the computerized system,maintenance of validation state of the computerized system,safety precautions of performance of the computerized system,as well as electronic records and electronic signatures with the purpose to provide some references for carrying out and speeding up the validation of computerized system and to further improve the efficiency of the computerized system in facilities for preclinical safety evaluation of drugs in China and to be in line with international practice.
