結(jié)合歐美國(guó)家對(duì)藥品非臨床研究質(zhì)量管理規(guī)范（GLP）實(shí)驗(yàn)室計(jì)算機(jī)化系統(tǒng)的規(guī)定,針對(duì)計(jì)算機(jī)化系統(tǒng)的特點(diǎn),對(duì)計(jì)算機(jī)化系統(tǒng)管理質(zhì)量保證（QA）的關(guān)鍵點(diǎn)進(jìn)行了探討與總結(jié),包括計(jì)算機(jī)化系統(tǒng)的驗(yàn)證、使用過(guò)程中的控制、定期維護(hù)及安全防護(hù)、電子數(shù)據(jù)的保存等方面,以期為國(guó)內(nèi)計(jì)算機(jī)化管理程度普遍不高的GLP實(shí)驗(yàn)室提供參考,提高藥品評(píng)價(jià)水平。得到的體會(huì)包括：通過(guò)多次檢查或?qū)彶?找出容易出問(wèn)題的地方,定為風(fēng)險(xiǎn)點(diǎn)；制定有針對(duì)性的QA檢查計(jì)劃,對(duì)計(jì)算機(jī)化系統(tǒng)著重實(shí)施基于風(fēng)險(xiǎn)的檢查,并針對(duì)發(fā)現(xiàn)的問(wèn)題適時(shí)調(diào)整QA的檢查計(jì)劃,保證QA的檢查或?qū)彶楦哂嗅槍?duì)性和有效性。

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.

重大新藥創(chuàng)制科技重大專項(xiàng)（2013ZX09302303，2012ZX09301-001-008）；北京市科委基金項(xiàng)目（Z131100006513010）