跨国制药行业的实验室管理系统设计与实现
发布时间：2018-11-23 10:13
【摘要】：辉瑞作为全球最大的制药公司,在北美,南美,欧洲以及亚太区域拥有众多的生产企业,这些生产企业负责生产药品活性成分,处方药品,非处方药品,营养品,疫苗等。辉瑞需要确保所有的生产企业的产品生产质量标准符合食品药品监督管理局(FDA)的法律法规。本文拟建立一个实验室管理系统,以能够在辉瑞的全球供应链网络中实现并且提供持续的业务价值,并且需要符合法规的一致性和提高生产效率。该实验室管理系统通过标准的业务运作和系统使用,支持实验室及质量保证,第三方合作方等方面的运作,在整个公司运作网络中统一并规范相关实验的分析方法,共享支持服务,降低运作成本。本论文主要内容包括:1.建立了覆盖样品,测试和测试结果的生命周期管理流程。2.构造了实验室管理系统的网络架构设计。3.开展了非标准的LIMS(实验室信息管理系统)数据库的设计实现。4.设计了批次创建,样品登录,样品分析,测试和样品审核,批次处置,SAP/LIMS接口,用户系统安全,并对其进行建模分析。5.实施并应用实验室管理系统作为应用验证,证明其满足了系统的业务需求。该实验室管理系统已成功在5个国家地区的实验室进行了部署实施,这个实验室信息管理系统的实施应用使得实验室运作实现了无纸化管理,共享静态数据,降低运作成本,提高了一致性和相容性,并且提高了效率和生产率。
[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.
【学位授予单位】：上海交通大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：TP311.52
[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.
【学位授予单位】：上海交通大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：TP311.52
【参考文献】
相关期刊论文 前3条
1 袁春森;;略谈实验室信息管理系统的设计及实现[J];硅谷;2008年06期
2 周蓓s，
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