21CFR Part 11: Electronic Signatures, Electronic Records

May, 2000 ASQ Presentation

The US Food and Drug Administration (FDA) has issued regulations that apply to the security of Electronic Signatures and Electronic Records. The Code of Federal Regulations, Section 21, Part 11 (21CFR11) is the model for information security being considered for all government agencies.

This talk describes the major characteristics of the regulations and implications for  software testing.

Talk presented at May 19, 2000 ASQ Silicon Valley Section Dinner Meeting.

21CFR11 Slides