醫療器材產品的技術日新月異，不但種類愈來愈多樣功能也愈趨進步，縮短研發與製造時程也隨著日益強大的競爭越顯重要，因此，企業必須尋找方法來提生研發與製造流程上之效率以保持競爭力。 與其他產業不同之處，醫療產品設計開發必須通過優良製造規範（Good Manufacture Practice，GMP）之驗證，設計過程須經過各階段安規測試，最後由食品藥物管理局（Food and Drug Administration，FDA）核准後驗證許可後產品方可生產、製造與販售。從專案建立到圖文修改、料號承認、工程物料清單建立的設計階段至移轉到量產階段之製造物料清單，在GMP品質管理要求下，中間繁瑣的資料交換與不同版本之產品生週期控管，須準確的紀錄並保持其可追溯性與所有核准歷程；另外，為了縮短上市時間，通常研發與認證需同時進行，製程中如果接獲核准，下道製程即可開始使用正式料號，因此跨部門資訊之傳遞須即時且準確。 應用同步工程於新產品發展過程，可整合各部門知識及作業資料，適切的資訊分配及作業控制，使開發周期縮短、品質提升而置成本降低；產品資料管理（Product Data Management，PDM）與資源規劃系統（Enterprise Resource Planning，ERP）整合基本資料與異動單據，可幫助產品認證與生產管理無縫接軌，PDM支撐研發團隊的資料管理流程，ERP精準量產製造達到高效能的整合。故研究方向分別就醫療器材企業之產品資料交換與共用流程兩方向，在符合法規之軟體確效（Software Validation，SV）要求下，提出PDM與ERP以同步工程（Concurrent Engineering，CE）架構之整合流程方法論以加速研發與製造流程效率。 ;Nowadays, the technology of medical device industry is growing rapidly around the world. It is not only the greater variety in product but also the increasingly complex in functionality. Therefore the companies must find ways to improve efficiency on design and manufacturing to speed up the process to sustain competitiveness. Medical Device industry is unique from an enterprise data management perspective is the amount of standards and regulations that must be observed. Good Manufacturing Practices (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards with the rigorous traceability of all development, manufacturing, and testing activities. In product life cycle, the version control of Part, BOM and Engineering Change are the crucial management of the GMP regulatory. The information transfers in interdepartmental needs to be accurate in time. Implement the Concurrent Engineering (CE) in new product development process is able to integrate knowledge and operational data of various departments to improve the quality of Product, shorten the Product life cycle and reduce the cost. System Validation (SV) is the technical discipline that Life Science companies use to ensure that each Information Technology application fulfills its intended purpose. This research focuses on adopting Concurrent Engineering methodology to perform data exchange between ERP and PDM system to achieve the data integrity, intension to reduce the level of effort in maintenance part and BOM information as well as increased accuracy. Meanwhile, the research proposed the Software Validation approach to proof the systems connection is compliance with GMP regulatory.
