Keeping abreast of evolving requirements for the management of documents and records means understanding the regulations and the current thinking on issues. 21 CRF Part 11, Electronic Records; Electronic Signatures is, by its very nature, a vague and indefinitely worded regulation. In 1997, when it was first issued, industry wasn't quite sure how it applied. Furthermore, fears of Y2000 issues with computer systems fueled the decision to remain paper-based, and the FDA itself was tasked with learning how exactly this law applied. In more than a decade, technology has improved, industry best practices have evolved to satisfy Part 11 requirements, and the agency has further defined its expectations for compliance with this law. This chapter addresses compliance with Part 11 and industry standards. It answers the following questions.