摘要
近年来计算机化系统在药物临床前安全评价中发挥越来越重要的作用,如直接或间接地用于试验数据的采集、处理、报告以及原始数据的存储等。但目前计算机化系统在我国药物临床前安全评价机构中应用尚未普及,或仅使用了计算机化系统部分模块功能。基于计算机化系统在我国药物临床前安全性评价机构的应用现状,简要介绍计算机化系统验证的GLP法规要求、计算机化系统验证的流程、计算机化系统验证状态的保持、计算机化系统运行需注意的安全事项以及电子记录和电子签名等内容,以期为药物临床前安全评价机构开展并加快计算机化系统验证提供一定参考,进一步提高我国药物临床前安全评价机构计算机化系统的使用效率并与国际接轨。
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.
出处
《药物评价研究》
CAS
2017年第11期1525-1530,共6页
Drug Evaluation Research
基金
十二五国家科技重大专项课题(2015ZX09501004-002)
十二五国家科技重大专项课题(2015ZX09501007-004)
关键词
药物
临床前安全性评价
计算机化系统
验证
drug
preclinical safety evaluation
computerized system
validation
