網(wǎng)絡(luò)和系統(tǒng)基礎(chǔ)設(shè)施是GLP實驗室計算機化系統(tǒng)的基本構(gòu)架，其驗證和管理工作對計算機化系統(tǒng)在GLP機構(gòu)中的有序運行至關(guān)重要?；A(chǔ)設(shè)施可在計算機化系統(tǒng)的系統(tǒng)生命周期中被驗證，也可獨立驗證。基礎(chǔ)設(shè)施驗證應(yīng)全面考慮其特殊方面如基礎(chǔ)設(shè)施配置、規(guī)模和復(fù)雜性、硬件和軟件以及網(wǎng)絡(luò)通信等，從而實現(xiàn)以監(jiān)管為目的的計算機化系統(tǒng)驗證。簡述了計算機化系統(tǒng)基礎(chǔ)設(shè)施的驗證方法和管理工作特性，以期為建立符合我國GLP原則和法規(guī)要求的計算機化系統(tǒng)提供支持和參考。

The network and system infrastructure are the basic framework of computerized system in the GLP laboratories, and their validation and management work is critical to the orderly operation of computerized systems in GLP organizations. The infrastructure can be validated during the system life cycle of a computerized system or independently. The validation of the infrastructure should take into account its specific aspects, such as infrastructure configuration, size and complexity, hardware and software, and network communications in order to achieve the validation of computerized system for regulatory purposes. Infrastructure validation methods, like system life cycle validation also involve the qualification or validation plans, requirementsspecification, qualification or validation reports, and operation and maintenance validation. This paper introduced in detail the feature of validation and management of infrastructure of computerized system so as to provide references for the establishment of computerized system that meet the requirements of GLP principles and regulations in China.

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