Abstract
Three and half years have already passed since the publication of 21 CFR Part 11 by FDA in August 1997. Although the electronic signatures and records in Part 11 were at first recognized as somewhat stringent regulations for legislative measures, the Part 11 has now been regarded to allow most of all activities in the pharmaceutical industry to be reviewed. At this moment, the unbiased study in the current status of 21 CFR Part 11 seems to be meaningful for Japanese industries. Some important key points of 21 CFR Part 11 are also to be so well detailed that the latest activities of PDA and ISPE in Part 11 should be introduced with some compliance strategy proposed for the Japanese pharmaceutical industry.
