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中国医药导刊 ›› 2020, Vol. 22 ›› Issue (1): 63-68.

所属专题: 智慧监管专栏 管理与实践-智能制造

• 管理与实践 • 上一篇    下一篇

试论甲方角度的制药企业智能制造或大型、复杂信息系统项目质量管理

赵琦,樊丽娟,罗云华   

  1. 昆明龙津药业股份有限公司
  • 收稿日期:2020-03-19 修回日期:2020-01-22 出版日期:2020-01-31 发布日期:2020-03-20
  • 基金资助:
    云南省2017年智能制造试点示范项目;云南省2018年中药饮片大健康产业发展专项项目

Discussion on the Pharmaceutical Enterprise Intelligent Manufacturing or Large and Complex Information System Project Quality Management from the Perspective of Party A

  1. Kunming Longjin Pharmaceutical Co
  • Received:2020-03-19 Revised:2020-01-22 Online:2020-01-31 Published:2020-03-20
  • Supported by:
    注射用冻干粉针剂智能工厂建设;注射用冻干粉针剂智能制造

摘要: 作为云南省2017年智能制造试点示范项目,注射用冻干粉针剂智能制造项目通过“全供应链集成、全信息化集成、全自动化集成”,使智能制造和制药工艺、管理流程深度融合,进行全过程的质量控制,同时进行数据全生命周期管理。由于本项目集规模大、投资大、周期长、复杂度高,创新性要求高,所以项目的实施是个持续改进的过程,过程中困难和问题层出不穷。为确保质量,项目管理特别是甲方的协作管理和整体协调,是项目集成功实施的关键。本文针对制药企业计算机化系统的特殊性,重新定义信息系统项目质量管理,从“项目集质量管理方法”和“基于甲方角度的项目集质量管理实践经验”两方面,对制药企业智能制造或信息化项目管理进行分析总结。建议甲方项目管理者一定要拥有全局性思维理解智能制造,充分发挥综合协调能力,首先体现数字化之上的确定性,逐步实现物理信息系统(CPS)的确定性。建议项目的规划、实施不要陷入极端,如不要超前追求极端的无人化、全覆盖等;在追求先进性的同时充分考虑适用性和经济性,做出理性的选择。

Abstract: As 2017 Yunnan province intelligen manufacturing pilot demonstration project, the construction of lyophilized powder injection intelligen manufacturing project has adopted “full supply chain integration, full information integration, and full automation integration” to deeply integrate intelligent manufacturing with pharmaceutical processes and management processes, perform quality control of the whole process, and data life cycle management at the same time. Because this project set is large in scale, large in investment, long in period, high in complexity and high in innovation requirements, the implementation of the project is a continuous improvement process, with difficulties and problems emerging in the process.To ensure quality, project management, especially Party A′s collaborative management and overall coordination, is the key to the success of the project. Aiming at the particularity of computerized information systems of pharmaceutical enterprises, this article redefines the quality management of information system projects, analyzes and summarizes the intelligent manufacturing or information system project management of pharmaceutical enterprises from the aspects of “program quality management methods” and “practice party quality management practice experience” for future reference.It is recommended that the project manager of Party A must have overall mind to understand intelligent manufacturing, give full play to comprehensive coordination capabilities, and first reflect the certainty over digitalization, and gradually realize the certainty of the physical information system (CPS). It is recommended that the planning and implementation of the project should not fall into extremes, such as don′t pursue extreme unmanned management and full coverage in advance. While pursuing advanced nature, fully consider applicability and economics, and make rational choices.

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