| 医疗器械生产企业质量检验信息化系统的研发和应用 |
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| 引用本文： | 林定余,郭永兵,朱清. 医疗器械生产企业质量检验信息化系统的研发和应用[J]. 中国医疗器械杂志, 2021, 0(1): 17-21 |
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| 作者姓名： | 林定余 郭永兵 朱清 |
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| 作者单位： | 宁波戴维医疗器械股份有限公司;浙江医药高等专科学校 |
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| 基金项目： | 浙江省高等教育“十三五”第一批改革研究项目(jg20180546)。 |
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| 摘 要： | 目的提高医疗器械生产企业生产和检验效率,提升企业质量体系管理水平,保障产品的安全有效.方法梳理生产企业业务流程,打通生产、检验和ERP系统数据库,搭建面向质量控制部门的操作软件.结果该系统已覆盖企业所有产品,实现检验过程的信息化和可视化.结论该系统的研发和应用能够完善生产企业质量管理追溯体系,提高产品质检效率和准确性.
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| 关 键 词： | 医疗器械生产企业 质量管理体系 信息化系统 质量检验 |
Research and Application of Quality Inspection Information System in Medical Device Manufacturers |
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| LIN Dingyu,GUO Yongbing,ZHU Qing. Research and Application of Quality Inspection Information System in Medical Device Manufacturers[J]. Chinese journal of medical instrumentation, 2021, 0(1): 17-21 |
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| Authors: | LIN Dingyu GUO Yongbing ZHU Qing |
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| Affiliation: | (Ningbo David Medical Device Co.Ltd.,Ningbo,315700;Zhejiang Pharmaceutical College,Ningbo,315100) |
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| Abstract: | Objective To improve the production and inspection efficiency of medical device manufacturers,improve the quality system management level of manufacturers,and ensure the safety and effectiveness of medical devices.Methods Sort out the business process of the medical device manufacturer,connect the database of production and ERP system to inspection system,and build the operation software for the quality control department.Results The system has covered all the products of the manufacturer,and has realized the informatization and visualization of the inspection process.Conclusion The research and application of the system can improve the quality management traceability system of medical device manufacturers,and improve the efficiency and accuracy of medical device quality inspection. |
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| Keywords: | medical device manufacturer quality management system information system quality inspection |
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