GLP機(jī)構(gòu)中使用的計(jì)算機(jī)化系統(tǒng)必須符合良好實(shí)驗(yàn)室規(guī)范的要求，為確保實(shí)驗(yàn)數(shù)據(jù)真實(shí)、安全、可靠，不但要對(duì)計(jì)算機(jī)化系統(tǒng)驗(yàn)證開展生命周期管理，而且要對(duì)系統(tǒng)生命周期活動(dòng)中涉及的人員的資質(zhì)、職責(zé)和培訓(xùn)提出要求，確保從計(jì)算機(jī)化系統(tǒng)的概念、需求、設(shè)計(jì)、開發(fā)、發(fā)布、操作使用及維護(hù)，直至系統(tǒng)退役及存檔的所有活動(dòng)均符合GLP要求。簡(jiǎn)要介紹計(jì)算機(jī)化系統(tǒng)驗(yàn)證生命周期的概念、內(nèi)容及主要任務(wù)，計(jì)算機(jī)化系統(tǒng)驗(yàn)證生命周期各階段的需求及特殊的考慮要點(diǎn)，以期為我國GLP機(jī)構(gòu)的計(jì)算機(jī)化系統(tǒng)開發(fā)、驗(yàn)證提供一定參考，進(jìn)一步提高計(jì)算機(jī)化系統(tǒng)的使用效率，確保數(shù)據(jù)的準(zhǔn)確性和可靠性，以加快我國GLP機(jī)構(gòu)臨床前藥物安全性評(píng)價(jià)數(shù)據(jù)的國際認(rèn)可。

Computerized systems used in GLP facilities are required to comply with regulations of good laboratory practice. To ensure the authentic, safe and reliable experimental data, it is not only necessary to carry out the management of the life cycle of computerized system validation, but also to make requirements for the qualifications, responsibilities and training of personnel involved in the system life cycle in order to ensure the concept, requirements, design, development, release, operation and maintenance, until retirement and archiving of the computerized system are in compliance with the requirements of GLP. This paper briefly introduces the concept, content and main tasks of the life cycle of computerized system, the requirements and special considerations of each stage of the life cycle of computerized system, in order to provide some references for the development and validation of computerized system in GLP facilities in China, to further improve the efficiency of computerized system and to ensure the accuracy and reliability of experimental data, and to accelerate the international mutual acceptance of experimental data from GLP facilities for preclinical safety evaluation of drugs in China.

R926

十三五重大新藥創(chuàng)制專項(xiàng)課題“創(chuàng)新藥物非臨床安全性評(píng)價(jià)研究關(guān)鍵技術(shù)”（2018ZX09201017）