現代化ERP系統透過提供以下資訊來幫助醫療設
備廠商實現合規性。
根據產品序列號跟蹤
以及日期和時間跟蹤
製造和購買零件，追
溯整個供應鏈流程。
可追溯性
Serial Number Tracking that allows unique identification for each item used in manufacturing or received...
Serial Number Tracking
完整的產品記錄和能
見度從工程到提交、
生產、完成和交付以
及服務和財務結算。
產品記錄
根據顯示在特定的報
告、標籤和搜索程式
上的批次級別追溯商
店編號和日期資訊。
批號屬性
透過庫存管理跟蹤從
生產到交付給客戶的
各個階段的進料批號。
庫存管理
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
可追溯性可以幫助企業確保合規性，快速識別產品召回並識別所用的材料。如果
採用紙張或試算表手動進行追溯查找，耗時且容易出錯。
使用科技進行追溯可確保產品的品質既符合要求又可滿意地交付給客戶。這可確保
整個流程均可追溯：在何時、何地由何人負責，一旦發生產品召回，可追溯性可幫
助識別受影響的產品最大程度地減少回收成本，並在客戶交付之前確定殘次品。
請瀏覽以下網站或電郵給我們,
瞭解Epicor ERP如何協助您的業務
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,
November 25, 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.
對變更進行控制和修
改，以設定權限存取
電子檔案，監視和跟
蹤變更，記錄修改者、
時間進行變更。
文件管理
醫療設備的可追溯性
確保患者安全
可追溯性是指能夠跟蹤從產品生產到整個生命週期的醫療設備。根據法規要求
（包括歐洲議會的2017/745法規），廠商必須制定醫療設備透明性和可追溯性
的規定。