近年來計算機化系統(tǒng)在藥物臨床前安全評價中發(fā)揮越來越重要的作用，如直接或間接地用于試驗數(shù)據(jù)的采集、處理、報告以及原始數(shù)據(jù)的存儲等。但目前計算機化系統(tǒng)在我國藥物臨床前安全評價機構中應用尚未普及，或僅使用了計算機化系統(tǒng)部分模塊功能。基于計算機化系統(tǒng)在我國藥物臨床前安全性評價機構的應用現(xiàn)狀，簡要介紹計算機化系統(tǒng)驗證的GLP法規(guī)要求、計算機化系統(tǒng)驗證的流程、計算機化系統(tǒng)驗證狀態(tài)的保持、計算機化系統(tǒng)運行需注意的安全事項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價機構開展并加快計算機化系統(tǒng)驗證提供一定參考，進一步提高我國藥物臨床前安全評價機構計算機化系統(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課題（2015ZX09501004-002）；十二五國家科技重大專項課題（2015ZX09501007-004）