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A制药公司质量事件管理信息系统设计和实施
Design and Implementation of Information System for Quality Event Management in A Pharmaceutical Company
【作者】 周燕;
【导师】 王海燕;
【作者基本信息】 东南大学 , 项目管理(专业学位), 2020, 硕士
【摘要】 随着计算机技术的飞速发展,计算机在企业管理中应用的普及,信息管理系统的开发和使用在强调管理、强调信息的现代社会中也显得越来越重要。利用计算机信息系统支持企业高效率的完成日常事务管理,是适应现代企业指定要求、推进企业管理走向科学化、规范化的必要条件。因此,在制造业日常管理中普遍使用信息系统的大环境下,为了提高企业对于质量事件管理日常工作的可控性、可追溯性、可查阅性,以此提高企业的合规性,以及工作效率,针对企业的需要,设计和实施质量事件管理信息系统。本文把A制药公司质量事件管理信息系统设计开发看成一个项目,利用项目管理思想,按照信息系统开发流程对该系统进行设计与实施。首先,查阅文献对国内外已有的相关研究进行调查,了解信息管理系统设计和开发、项目管理在信息管理系统开发中的应用,以及质量管理信息系统设计和运用的现状;然后,通过头脑风暴法、流程调查法、问卷调查法等深入分析A制药公司质量事件管理信息系统的用户需求;再根据汇总的用户需求,讨论系统的总体功能设计,并对系统的组织功能设计、业务流程设计、系统范围设计和数据流程设计进行讨论和提出解决方案。在系统实施阶段,为保证系统能在规定的时限内顺利上线运行,研究并进行系统实施进度控制;在系统测试过程中进行风险管理,并提出系统实施的具体策略。通过本文的研究,设计和实现使用便捷、针对性强的A制药公司质量事件管理信息系统,实现了企业对质量事件管理无纸化的要求,提高了工作效率以及工作流程的合规性。本文的研究过程可为其他同类企业质量管理信息系统的设计开发提供参考。
【Abstract】 With the rapid development of computer technology,and the popularization of computer in enterprise management,the development of information management system is becoming more and more important at current society,which is emphasizing management and information.Therefore,using computer information system to support the company to conduct daily business management with high efficiency,is the necessary condition for adapting the specific requirements of current company,promoting the scientific and standardization of management in company.Therefore,under currently background of using information system for the daily management of manufacturing industry,in order to improve the controllability,traceability and accessibility of the quality event management during the daily work,so as to improve the compliance of enterprises,the quality event management information system is designed and implemented according to the needs of enterprises.In this article,the design and development of quality event management information system of A pharmaceutical company is regarded as a project,using the idea of project management to design and implement this system following the development process of an information system.First,reviewing the literatures to recognize the existing situation about the relevant studies domestic and abroad.Then,using brainstorming method,process investigation and questionnaire etc.,to further understand the users demands of this quality event management information system of A pharmaceutical company;Based on the user requirements,design the system structure functions,discuss and provide solution for organization design,business process design,system scope design and data flow design of the information system.In the implementation step of the system,to ensure the system could be started for business using as per the required timeline,discuss and conduct how to use the project schedule management to control the progress of system conducting,discuss the risk management during system testing,and propose the strategy of the system implementation.Through this study,design and rollout a convenient quality event management information system for A pharmaceutical company quality event management,make the quality event management of the enterprise become paper-free,increase the work efficiency and compliance.This study could provide experience and reference for the process management of other similar quality management information system development in other enterprises of pharmaceutical industry.
- 【网络出版投稿人】 东南大学 【网络出版年期】2022年 08期
- 【分类号】TP315;F273.2;F426.72
- 【下载频次】74