FDA

21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule-March 20, 1997

Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices-September 9, 1999

Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Validation-August 2001

Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Glossary of Terms-August 2001

General Principles of Software Validation; Final Guidance for Industry and FDA Staff -January 11, 2002

Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Electronic Copies of Electronic Records-August 2002

Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application-August 2003

Guidance for Industry Providing Regulatory Submissions in Electronic Format — General Considerations-October 2003

Guidance for Industry Cybersecurity for Networked Medical Devices Containing Off- the-Shelf (OTS) Software-January 14, 2005

Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility -October 2007