抄録
It is recommended that organization shall have a reasonable timetable for promptly modifying any systems not in compliance (including legacy systems) to make them Part11 compliant, and shall be able to demonstrate progress in implementing their timetable. The reasons: 1. It takes not so much time to recognize Part11 requiring implementation of secure, computer-generated and time-stamped audit trails etc. as global standard. 2. The Japanese pharmaceutical companies are faces to important phase to decide the implementation of Part11 in their process of globalization. 3. It may take more time to modify the existing systems such as for R&D of new medicine, manufacturing and quality control management of products.
