As the overall environment in the biomedical manufacturing industry has been changing, the US Federal Judiciary system has implemented regulations on the use of electronic documents during their lifecycle in Chapter 21 Article 11 of FDA21CFR Part 11. This project aims to establish a database system for management of biomedical documents and provide international certification agencies a contact with the biomedical industry in Taiwan. The electronic documents in the database meet the application standards of the US FDA for approval of biomedical products prior to market entry as stipulated in FDA21CFR Part 11 and are intended to establish an "Integrated Platform for Certification of Biomedical Documents" and lower the threshold for entrance into the field of biomedical research and development and ultimately achieve the goal of industrial upgrading.

This project aims to establish a management database system for biomedical documents. This system will have built-in document templates that meet international standards, common technical document modules and electronic signature and document evaluation procedures. At the same time, the system will also have document samples compatible with the format of the application form for marketing approval regulationsas stated in US FDA in FDA21CFR Part 11.

The project will be completed and fully online by December 31st 2007