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.

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

The purpose of this ISPE White Paper is to describe 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 (August 2003)

The purpose of this guidance is to describe the FDA's re-examination of 21 CFR Part 11.

Complying with 21 CFR Part 11, Electronic Records and Electronic Signatures, Part 2 (September 2001)

This document produced by ISPE and PDA was developed to provide a better understanding of 21 CFR Part 11. It aims to provide guidance for the industry on how to comply with the requirements.

Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures Time Stamps (February 2002)

The purpose of this draft guidance is to describe the FDA's current thinking regarding the time stamp requirements of 21 CFR Part 11.