| 摘要(英) |
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. |
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