【摘要】：輝瑞作為全球最大的制藥公司,在北美,南美,歐洲以及亞太區(qū)域擁有眾多的生產(chǎn)企業(yè),這些生產(chǎn)企業(yè)負責(zé)生產(chǎn)藥品活性成分,處方藥品,非處方藥品,營養(yǎng)品,疫苗等。輝瑞需要確保所有的生產(chǎn)企業(yè)的產(chǎn)品生產(chǎn)質(zhì)量標(biāo)準符合食品藥品監(jiān)督管理局(FDA)的法律法規(guī)。本文擬建立一個實驗室管理系統(tǒng),以能夠在輝瑞的全球供應(yīng)鏈網(wǎng)絡(luò)中實現(xiàn)并且提供持續(xù)的業(yè)務(wù)價值,并且需要符合法規(guī)的一致性和提高生產(chǎn)效率。該實驗室管理系統(tǒng)通過標(biāo)準的業(yè)務(wù)運作和系統(tǒng)使用,支持實驗室及質(zhì)量保證,第三方合作方等方面的運作,在整個公司運作網(wǎng)絡(luò)中統(tǒng)一并規(guī)范相關(guān)實驗的分析方法,共享支持服務(wù),降低運作成本。本論文主要內(nèi)容包括:1.建立了覆蓋樣品,測試和測試結(jié)果的生命周期管理流程。2.構(gòu)造了實驗室管理系統(tǒng)的網(wǎng)絡(luò)架構(gòu)設(shè)計。3.開展了非標(biāo)準的LIMS(實驗室信息管理系統(tǒng))數(shù)據(jù)庫的設(shè)計實現(xiàn)。4.設(shè)計了批次創(chuàng)建,樣品登錄,樣品分析,測試和樣品審核,批次處置,SAP/LIMS接口,用戶系統(tǒng)安全,并對其進行建模分析。5.實施并應(yīng)用實驗室管理系統(tǒng)作為應(yīng)用驗證,證明其滿足了系統(tǒng)的業(yè)務(wù)需求。該實驗室管理系統(tǒng)已成功在5個國家地區(qū)的實驗室進行了部署實施,這個實驗室信息管理系統(tǒng)的實施應(yīng)用使得實驗室運作實現(xiàn)了無紙化管理,共享靜態(tài)數(shù)據(jù),降低運作成本,提高了一致性和相容性,并且提高了效率和生產(chǎn)率。
[Abstract]:Pfizer, the world's largest pharmaceutical company, has a large number of manufacturing companies in North, South America, Europe and the Asia-Pacific region, which produce active ingredients, prescription drugs, over-the-counter drugs, nutrients, vaccines, etc. Pfizer needs to ensure that all manufacturing companies produce quality standards in compliance with the FDA's (FDA) regulations. In this paper, a laboratory management system is proposed to achieve and provide continuous business value in Pfizer's global supply chain network, and to comply with regulatory consistency and improve production efficiency. The laboratory management system through standard business operations and system use, support laboratory and quality assurance, third-party partners and other aspects of the operation of the company throughout the network of unified and standardized related laboratory analysis methods, Share support services and reduce operating costs. The main contents of this thesis are as follows: 1. Established a lifecycle management process covering sample, test and test results. 2. The network architecture design of laboratory management system is constructed. 3. The design and implementation of the non-standard LIMS (Laboratory Information Management system) database is carried out. 4. Design batch creation, sample login, sample analysis, test and sample audit, batch disposal, SAP/LIMS interface, user system security, and model analysis. 5. Implementation and application of laboratory management system as application verification, it is proved that it meets the business needs of the system. The laboratory management system has been successfully deployed and implemented in laboratories in five countries. The implementation of the laboratory information management system has enabled the laboratory to achieve paperless management, share static data, and reduce operating costs. Improved consistency and compatibility, and increased efficiency and productivity.
【學(xué)位授予單位】：上海交通大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：TP311.52

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相關(guān)期刊論文 前3條

1 袁春森;;略談實驗室信息管理系統(tǒng)的設(shè)計及實現(xiàn)[J];硅谷;2008年06期

2 周蓓s，

本文編號：2351223