联系我们

论文查询结果	返回搜索

论文编号：	13400
作者编号：	2320180618
上传时间：	2022/6/14 16:52:58
中文题目：	跨国医药企业G公司CSV实施管理策略研究
英文题目：	Research on CSV implementation strategy of multinational pharmaceutical enterprise G company
指导老师：	林润辉
中文关键字：	计算机化系统验证; 质量管理；PDCA;全生命周期管理
英文关键字：	CSV; Quality Assurance; PDCA; Life cycle management
中文摘要：	智能化发展与质量合规提升是医药企业发展的关键路径。在国家“中国制造2025”的政策指引和医药体制改革升级的大背景下，医药企业开始发力向智能化发展，利用信息技术拉动企业的发展，提升行业竞争力。另一方面，医药企业面临的监管要求不断提升，生产和流通相关法规和附录多次修正与更新，药品监管部门对制药企业的监管重点渗透到药品生命周期的各个环节，“飞行检查”已成为常态，违规行为将受到严惩，面临着巨大的经济上和企业信誉上的损失。 医药企业需要更科学有效且配合智能化发展的质量管理。医药企业协同IT供应商运用信息化技术加强企业质量自控水平、智能化水平、生产效率是目前医药企业发展的趋势。满足国家新版GMP要求的CSV（Computerized System Validation, 计算机化系统验证）成为管理医药企业质量控制的重要环节。伴随国家 GMP附录《计算机化系统》、《验证与确认》、《药品数据管理规范》等法规的出台，确保医药企业计算机系统通过CSV验证，符合政府部门的规定以及法律要求成为当前医药企业信息化系统管理的重要内容。 本文对医药企业G公司计算机化系统验证的强制性和必需性为研究背景，从实施方的角度以G公司CSV项目面临的问题为研究对象，以成功交付CSV项目为研究重点。采用理论与案例相结合的方式，运用了系统全生命周期方法、PDCA循环方法、验证软件V模型和项目管理的理论为行动指南，结合GAMP5指南和GMP法规要求中的研究方法论，详细研究了跨国大型医药企业应用管理手段优化CSV项目的实施策略。 本文希望通过以G公司CSV项目实施的经验总结以及科学化的计算机系统合规管理模式的落地，促进CSV项目实施的合规性、可控性，同时为CSV项目实施方提升CSV项目实施质量提供借鉴。 本文图25幅，表23个，参考文献36篇 关键词： 计算机化系统验证; 质量管理；PDCA;全生命周期管理。
英文摘要：	Intelligent development and quality compliance improvement are the key path for the development of pharmaceutical enterprises. Under the background of the national policy guidance of "made in China 2025" and the reform and upgrading of the pharmaceutical system, pharmaceutical enterprises began to develop towards intelligence, use information technology to stimulate the development of enterprises and enhance the competitiveness of the industry. On the other hand, the regulatory requirements faced by pharmaceutical enterprises have been continuously improved, and the relevant laws and regulations and appendices on production and circulation have been revised and updated for many times. The regulatory focus of pharmaceutical enterprises by drug regulatory authorities has penetrated all links of the drug life cycle. The "flight inspection" has become the norm. Violations will be severely punished and face huge economic and corporate reputation losses. Pharmaceutical enterprises need more scientific and effective quality management with intelligent development. Pharmaceutical enterprises cooperate with it suppliers to use information technology to strengthen enterprise quality self-control level, intelligent level and production efficiency is the development trend of pharmaceutical enterprises at present. CSV (computerized system validation), which meets the requirements of the new national GMP, has become an important link in the quality control of pharmaceutical enterprises. With the promulgation of the national GMP appendix "computerized system", "verification and validation", "drug data management specification" and other regulations, ensuring that the computer system of pharmaceutical enterprises passes the CSV verification and complies with the provisions of government departments and legal requirements has become an important content of the current information system management of pharmaceutical enterprises. This article takes the compulsion and necessity of computerized system verification of G company as the research background, takes the problems faced by G company's CSV project as the research object from the perspective of the implementer, and focuses on the successful delivery of CSV project. Using the combination of theory and case, using the system life cycle method, PDCA cycle method, verification software V model and project management theory as the action guide, combined with the research methodology in GAMP5 guide and GMP regulatory requirements, this paper studies in detail the implementation strategy of applying management means to optimize CSV project in multinational large pharmaceutical enterprises. This article hopes to promote the compliance and controllability of CSV project implementation by summarizing the experience of CSV project implementation of G company and the implementation of scientific computer system compliance management mode, and provide reference for CSV project implementers to improve the implementation quality of CSV project. This paper has 25 figures, 23 tables and 36 references Keywords: CSV; Quality Assurance; PDCA; Life cycle management.
查看全文：	预览  下载(下载需要进行登录)