結合歐美國家對藥品非臨床研究質量管理規(guī)范（GLP）實驗室計算機化系統(tǒng)的規(guī)定,針對計算機化系統(tǒng)的特點,對計算機化系統(tǒng)管理質量保證（QA）的關鍵點進行了探討與總結,包括計算機化系統(tǒng)的驗證、使用過程中的控制、定期維護及安全防護、電子數據的保存等方面,以期為國內計算機化管理程度普遍不高的GLP實驗室提供參考,提高藥品評價水平。得到的體會包括：通過多次檢查或審查,找出容易出問題的地方,定為風險點；制定有針對性的QA檢查計劃,對計算機化系統(tǒng)著重實施基于風險的檢查,并針對發(fā)現的問題適時調整QA的檢查計劃,保證QA的檢查或審查更具有針對性和有效性。

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（2013ZX09302303，2012ZX09301-001-008）；北京市科委基金項目（Z131100006513010）