Quality assurance of computerized system for GLP laboratory
10.7501/j.issn.1674-6376.2017.04.001
- VernacularTitle:GLP实验室计算机化系统质量保证关键点的探讨
- Author:
Hong LI
;
Chunqi WU
;
Gang HAN
;
Yansheng DONG
;
Qiaozhen GUO
;
Jianjing WANG
;
Shufang WAN
;
Huazhi MA
;
Quanjun WANG
- Keywords:
computerized system;
GLP laboratory;
quality assurance (QA);
drug evaluation
- From:
Drug Evaluation Research
2017;40(4):433-436,491
- CountryChina
- Language:Chinese
-
Abstract:
In view of the characteristics of the computerized system,the key points in the quality assurance (QA) of the computerized system was discussed and summarized combined with the requirements of the GLP laboratory in Europe and America.The validation of computerized system,the control during the use of computerized system,period maintenance and safety protection of computerized system,archives of electronic data was discussed,expecting to provide reference for the management of computerized system in Chinese GLP laboratory which is generally not high currently.The experiences were obtained as follow:Through repeated inspection and review,the problem was found and set as the risk point;a targeted QA inspection plan was made focusing on the risk-based inspection and the QA inspection plan was timely adjusted according to the problems,which ensures the pertinence and validity of the QA inspection.
