近年來計(jì)算機(jī)化系統(tǒng)在藥物臨床前安全評(píng)價(jià)中發(fā)揮越來越重要的作用，如直接或間接地用于試驗(yàn)數(shù)據(jù)的采集、處理、報(bào)告以及原始數(shù)據(jù)的存儲(chǔ)等。但目前計(jì)算機(jī)化系統(tǒng)在我國藥物臨床前安全評(píng)價(jià)機(jī)構(gòu)中應(yīng)用尚未普及，或僅使用了計(jì)算機(jī)化系統(tǒng)部分模塊功能?；谟?jì)算機(jī)化系統(tǒng)在我國藥物臨床前安全性評(píng)價(jià)機(jī)構(gòu)的應(yīng)用現(xiàn)狀，簡要介紹計(jì)算機(jī)化系統(tǒng)驗(yàn)證的GLP法規(guī)要求、計(jì)算機(jī)化系統(tǒng)驗(yàn)證的流程、計(jì)算機(jī)化系統(tǒng)驗(yàn)證狀態(tài)的保持、計(jì)算機(jī)化系統(tǒng)運(yùn)行需注意的安全事項(xiàng)以及電子記錄和電子簽名等內(nèi)容，以期為藥物臨床前安全評(píng)價(jià)機(jī)構(gòu)開展并加快計(jì)算機(jī)化系統(tǒng)驗(yàn)證提供一定參考，進(jìn)一步提高我國藥物臨床前安全評(píng)價(jià)機(jī)構(gòu)計(jì)算機(jī)化系統(tǒng)的使用效率并與國際接軌。

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.

十二五國家科技重大專項(xiàng)課題（2015ZX09501004-002）；十二五國家科技重大專項(xiàng)課題（2015ZX09501007-004）