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中華職業醫學雜誌

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篇名 如何應用虛擬機器管理實驗室分析儀器之原始資料以符合認證要求
卷期 26:3
並列篇名 Management of laboratory instruments of raw data via virtual machine applications for meeting certification requirements
作者 劉凱中蘇家玉利琇美徐瑜敏張錦標
頁次 205-212
關鍵字 虛擬機器Oracle VirtualBox軟體備份資料認證Virtual MachineOracle VirtualBox softwareback up datacertificationTSCI
出刊日期 201907

中文摘要

目的:本研究透過虛擬機器(virtual machine)有效管理分析儀器的分析結果、校正、品管、試劑、及異常事件等紀錄,以符合認證要求,大量數據也可做為資料分析之依據。材料與方法:以Sysmex XN-3000、UF-1000i與CS-1600儀器端電腦轉為虛擬機器。使用Oracle VirtualBox軟體進行測試,建置一台實體機器存放多個虛擬機器。測試期間為107年5月至107年7月。XN-3000:每日備份分析紀錄及每月完整備份。CS-1600:每日備份分析紀錄及每月備份資料庫及設定檔。UF-1000i:每月備份資料庫及設定檔。XN-3000與CS-1600每日備份分析紀錄各60筆,及XN-3000、CS-1600與 UF-1000i備份每月資料庫及設定檔各3筆。結果:建置後:(1)降低原始資料備份的複雜度,及減少人為的疏失及遺漏,由0.8%下降至0.0%。(2)蒐集巨量資料,備份資料屬性XN-3000由15項增加到559項、CS-1600由4項增加到47項,以及UF-1000i由7項增加到21項。(3)提高資料保存期限:各項紀錄可由虛擬機器存取,將資料保存期限由最短CS-1600於儀器端僅可存放2.5個月,透過結合每月系統完整備份與虛擬主機不受主機硬體限制的特性,不會因為硬體老舊而無法運作。結論:目前分析儀器都有獨立的windows作業系統,可透過虛擬機器進行資料的備份,也可以進行序列連接埠或網路連接埠的模擬,不受電腦規格的限制。未來可以評估直接連結分析儀器做為主機備援電腦之可行性。可將資料保存期限提升到永久保存或至指定廢止期限,符合認證要求。

英文摘要

Purpose: This study effectively manages the analysis results, calibrations, quality controls, reagents, and non-conformity events of analytical instruments through virtual machines to meet certification requirements. A large amount of data can also be used as the basis for data analysis. Materials and methods: Instrument computers of the Sysmex XN-3000, UF-1000i and CS-1600 systems were converted into virtual machines. Oracle VirtualBox software was used to test performance and a real machine containing multiple virtual machines was established. The study was performed from May to July, 2018. Each instrument system has its tasks: XN-3000 system conducts daily backup of analysis records and monthly full backups; CS-1600 system conducts daily backup of analysis records and monthly database and configuration files backups; UF-1000i conduct monthly database and configuration files backups. XN-3000 and CS-1600 individually make daily backup of 60 analysis records; in addition, XN-3000, CS-1600 and UF-1000i individually make monthly backup of 3 database and configuration files. Results: The advantages of establishment were found: (1) complexities of original data backups, human error and data loss were decreased from 0.8% to 0.0%. (2) large amount of data collections and backups of XN-3000, CS-1600 and UF-1000i systems were expanded from 15 to 559 items, 4 to 47 items, and 7 to 21 items, respectively. (3) An increase of data storage: each of records can be downloaded and saved from virtual machines and data storage can be lasted for 2.5 months at least for CS-1600 systems with combination of monthly systems backups. Moreover, virtual machines function well despite aging hardware. Conclusions: Each instrument has its individual windows operating systems at present, so making database backups and simulations of serial connections and network connections can be performed via virtual machines without limitation of computer specifications. In the future, it is possible to evaluate the feasibility of direct link-up of analytical instruments as a host backup computer. Data storage can be lasted permanently or abolished at designated dates to meet certification requirements.

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