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November 2007 Reflection Paper on Expectations for Electronic Source Documents Used in Clinical Trials (EMEA GCP Inspectors Working Group).
May 2007 Guidance for Industry: Computerized Systems Used in Clinical Investigations.
undated Risk-Based Approach to 21 CFR Part 11.
May 2005 Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
November 2006 Leveraging the CDISC Standards to Facilitate the use of Electronic Source within Clinical Trials (Final).
September 2005 Leveraging the CDISC Standards to Facilitate the use of Electronic Source within Clinical Trials (Draft).
August 2003 Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application.
February 2003 Draft Guidance for Industry on 'Part 11, Electronic Records, Electronic Signatures - Scope and Application.
January 2002 General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
November 2000 Legal Considerations in Designing and Implementing Electronic Processes: A Guide for Federal Agencies.
October 2000 Records Management Guidance for Agencies Implementing Electronic Signature Technologies.
September 1999 Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software use in Medical Devices.
April 1999 Guidance for Industry: Computerized Systems Used in Clinical Trials.
March 1997 Electronic Records; Electronic Signatures; Final Rule.

This page last modified on:
Fri Feb 3 2012