【摘要】：驗(yàn)證就是一個(gè)文件記錄的過(guò)程,是要高度證明計(jì)算機(jī)系統(tǒng)在其整個(gè)系統(tǒng)生命周期中,能在受控狀態(tài)下正確而始終如一地執(zhí)行其設(shè)計(jì)功能的要求。根據(jù)監(jiān)管要求驗(yàn)證過(guò)程始于系統(tǒng)設(shè)計(jì)/用戶(hù)要求階段,延續(xù)至使用和維護(hù),直至最終退役和電子記錄的保存。這樣做的目的是確保每個(gè)信息技術(shù)應(yīng)用程序都能達(dá)到其預(yù)期的功能目的。臨床研究中的計(jì)算機(jī)系統(tǒng)的驗(yàn)證是GCP的要求,以滿(mǎn)足相關(guān)產(chǎn)品預(yù)設(shè)的質(zhì)量、安全以及可追溯性的要求。本文描述企業(yè)如何按照驗(yàn)證標(biāo)準(zhǔn)操作規(guī)程(SOP),確定相關(guān)責(zé)任人,執(zhí)行驗(yàn)證的工作。驗(yàn)證過(guò)程中的特定工作可以外包,但是系統(tǒng)驗(yàn)證的最終責(zé)任人始終是業(yè)務(wù)過(guò)程的所有者,即申辦者。為了提供證據(jù)證明系統(tǒng)已經(jīng)并繼續(xù)處于已驗(yàn)證狀態(tài),必須建立詳細(xì)的驗(yàn)證程序,并提供適當(dāng)?shù)呐嘤?xùn)以及足夠的文件。驗(yàn)證過(guò)程的質(zhì)量也需要經(jīng)質(zhì)量控制(QC)與質(zhì)量保證(QA)加以維護(hù)。
[Abstract]:Verification is a process of document recording, which is the requirement that a computer system can perform its design function correctly and consistently in a controlled state throughout its system life cycle. The verification process according to regulatory requirements begins at the system design / user requirement stage and continues to use and maintain until final decommissioning and electronic record keeping. The goal is to ensure that every IT application achieves its intended functional purpose. The verification of computer systems in clinical studies is required by GCP to meet the preset quality, safety, and traceability requirements of related products. This paper describes how enterprises determine the responsible persons according to the verification standard operating procedures (SOP),) and perform verification work. The specific work in the verification process can be outsourced, but the ultimate responsibility of the system verification is always the owner of the business process, that is, the applicant. In order to provide evidence that the system has been and continues to be validated, detailed verification procedures must be established, appropriate training and adequate documentation must be provided. The quality of the verification process also needs to be maintained by quality control (QC) and quality assurance (QA).
【作者單位】： 中國(guó)臨床試驗(yàn)數(shù)據(jù)管理學(xué)組;
【分類(lèi)號(hào)】：R969.4

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