抄録
In 1997, FDA issued new reguration about electronic records/eletronic signature and handwritten signature at the behest of pharmaceutical industry. Advantage of this reguration, pharmaceutical company will have oppotunity of building paperless factory and also will take many benefit like searching large volume of data or speeding up inspection. On the other hand, there are problems that the risks of falsification are higher with electronic records than paper records. 21 CFR Part11 indicate requrement items which solve weakness of electronic records, but it still having many difficulties in actual implementation because of interpretation of Part11 rules and technical problems.
