采用計算機(jī)化系統(tǒng)進(jìn)行數(shù)據(jù)采集和分析是目前藥物臨床前安全性評價研究的趨勢，由此產(chǎn)生的計算機(jī)化系統(tǒng)安全性問題成為GLP機(jī)構(gòu)以及行政管理監(jiān)督部門關(guān)注的重點(diǎn)。作者從計算機(jī)化系統(tǒng)安全性的概念及范圍、安全要素以及安全事件的管理等方面進(jìn)行了簡要闡述，以期為我國藥物臨床前安全性評價GLP機(jī)構(gòu)中計算機(jī)化系統(tǒng)的廣泛應(yīng)用提供支持和幫助，從而促進(jìn)我國藥物研發(fā)以及安全性評價策略與國際接軌。

The use of computerized system for data acquisition and analysis is currently the trend of preclinical safety evaluation of drugs, so the security of computerized system has become the focus of GLP institutes and administrative supervision department. The author of the paper briefly introduces the concept, scope, security elements of computerized system and management of security incidents so as to provide supports and help for the wide application of computerized system in GLP institutes for preclinical safety evaluation of drugs in China, and thus promoting the research and development and safety evaluation strategy of drugs in line with international standards.

R951

十三五重大新藥創(chuàng)制專項（2018ZX09201-017）