21 CFR Part 11

Electronic Records; Electronic Signatures Final Rule, 62 Federal Register 13430 (March 20, 1997)

This Code of Federal Regulation is the official rule on Electronic Records and Electronic Signatures management for FDA-audited industries.

Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11-Questions and Answers; Draft Guidance for Industry; Availability (June 21, 2017)

This draft document provides guidance to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under part 11 in clinical investigations of medical products.

Risk-Based Approach to 21 CFR Part 11 (August 2003)

This ISPE White Paper describes how a risk-based approach to Part 11 could be used to benefit patient health while adversely impacting industry productivity.

Guidance for Industry, Part 11, Electronic Records; Electronic Signatures - Scope and Application (September 2003)

This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).