醫療器材專案資訊系統之建構-以A公司為例

Abstract

醫療器材為我國生技產業中成長最為快速的領域，其產品設計與開發過程中的品質紀錄需確實保存，以符合ISO 13485中對於品質紀錄管制之規範。本研究中之案例A公司準備將產品的觸角延伸至醫療器材領域，該公司的品質系統為符合ISO 13485:2003對於品質紀錄管制的規範，需將產品設計與開發的相關紀錄，包含產品要求、設計與開發的輸入、輸出、審查、驗證、確效和變更等內容加以記錄與保存，以利在必要時追溯相關的品質紀錄。而A公司目前以人力與紙本作業的方式保存專案資訊，除了常因資訊不透明造成溝通失當影響專案進度外，也常發生文件或重要紀錄錯置或遺失的情況。為符合ISO 13485之規範並解決A公司品質紀錄管控的問題，本研究為該公司建構一套醫療器材專案資訊系統，以網頁系統配合相關的資料庫，統一儲存專案的各項資訊，並提供文件簽呈與紀錄查詢的功能，協助A公司妥善地保存專案資訊與品質紀錄。

Medical equipment is the fastest-growing domain among Taiwan’s Biotech industry. The quality records of product design and development process need to be preserved appropriately in order to comply with the standard for ISO13485. In the case study, A company plans to extend the product's reach to the medical equipment field. In order to make the company's quality system meet the ISO 13485:2003 specifications, the company needs to record and preserve all the related information of product design and development, including product requirements, design and development input, output, review, verification, validation, and modification, etc. so as to trace related quality records if needed. However, the recent method that A company use to preserve the project information with man power and paper work usually causes miscommunication and then delay the project schedule due to the undisclosed information. In addition, this improper preserving method usually causes the lost or misplace of the important documents and records. To comply with the standard ISO 13485 and to solve A company’s quality record control problem, this study helped the company to construct a set of medical equipment project information web-base system with related database so that all the project information can be stored in it. Besides, the system also provides the function of on-line sign-off and records searching. With the help of this system, A company may preserve the project information and quality records properly.