现代化ERP系统透过提供以下信息来帮助医疗设
备制造商确保合规性。
根据产品序列号，以
及日期和时间，跟踪
制造和购买的零件，
追溯整个供应链流程。
可追溯性
Serial Number Tracking that allows unique identification for each item used in manufacturing or received...
Serial Number Tracking
完整的产品记录，可
以查看从项目设立到
提交、生产、完成和
交付以及服务和财务
结算的所有内容 。
产品记录
在特定报告、标签
和搜索程序上,显示
存储在批次级别跟踪
的编号和日期信息。
批号属性
库存管理跟踪从生产
到交付给客户的各个
阶段的原材料批号。
库存管理
Information captured for each serial number aids in specifying products for recall and helps identify defect sources
Define the parameters used for serial number generation
Generate serial numbers at the component level to connect parent and child assemblies for tracking
可追溯性可帮助您确保合规性，快速识别产品召回，并获得对所用材料的可见性。
但是，依赖纸张或电子表格使得可追溯性成为一项手动、耗时且容易出错的任务。
使用科技进行追溯可确保产品的质量既符合要求又可满意地交付给客户。这可确
保整个流程均可追溯：在何时、何地由何人负责，一旦发生产品召回，可追溯性
可帮助识别受影响的产品，最大程度地减少回收成本，并在客户交付之前识别缺陷。
了解更多Epicor ERP如何
帮助您的业务，请访问：
888.463.4700
The contents of this document are for informational purposes only and are subject to change without notice. Epicor Software Corporation makes no guarantee, representations, or warranties with regard to the enclosed information and specifically disclaims, to the full extent of the law, any applicable implied warranties, such as fitness for a particular purpose, merchantability, satisfactory quality, or reasonable skill and care. The results represented in this testimonial may be unique to the particular customer as each user’s experience will vary. This document and its contents, including the viewpoints, testimonials, dates, and functional content expressed herein are believed to be accurate as of its date of publication,
December 9, 2020. Use of Epicor products and services are subject to a master customer or similar agreement. Usage of the solution(s) described in this document with other Epicor software or third-party products may require the purchase of licenses for such other products. Epicor, the Epicor logo are trademarks or registered trademarks of Epicor Software Corporation in the United States, and in certain other countries and/or the EU. Microsoft is a registered trademark of Microsoft Corporation in the United States and other countries.
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...into inventory from manufacturing or purchasing:
• Information captured for each serial number aids in specifying products for recall and helps identify defect sources
• Define the parameters used for serial number generation
• Generate serial numbers at the component level to connect parent and child assemblies for tracking
READ MORE
Traceability means being able to trace a medical device from production through its full life cycle. In order to meet regulatory demands—including Regulation 2017/745 of the European Parliament—manufacturers must have provisions in place for transparency and traceability of medical devices.
New EU medical device regulations state that all medical devices must have a Unique Device Identification (UDI) to help track and identify medical devices through their life—across manufacturing, distribution, and use.
变更控制和修订，控
制谁有权访问电子文
件，监控和跟踪变更，
记录何时进行变更以
及谁在进行变更。
文件管理
医疗设备的可追溯性
确保患者安全
可追溯性意味着能够从生产到整个生命周期跟踪医疗器械。为了满足监管要求
（包括欧洲议会的2017/745法规号），制造商必须制定医疗设备透明性和可追
溯性的规定。