Guidance For Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Time Stamps

摘要

The purpose of this draft guidance is to describe the Food and Drug Administration's (FDA's) current thinking regarding the time stamp requirements of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures. It provides guidance to industry, and is intended to assist persons who are subject to the rule to comply with the regulation. It may also assist FDA staff who apply part 11 to persons who are subject to the regulation.