Dissecting the 21 CFR Part 11 Controversy

摘要

The original intent of the 21 CFR Part 11, pertaining to the use of electronic records and signatures, was to encourage industry to adopt new technologies, but the regulation turned out to have a totally opposite effect. The revision of its guidance documents and the continuous redirection of this rule do not end the confusion and discussion of this subject. This paper attempts to diagnose the problems of Part 11 within the framework of the three main root causes identified in Gordon B. Richman's "The Part 11 Controversy A Root Cause Analysis and Science-Based Solutions," and explores the proposed risk-based remediation.