21 CFR Part 11

21 CFR Part 11 – 2003 Guidance

This course covers the August 2003, US FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application, establishing the enforcement discretion to the regulation, 21 CFR Part 11. In this course we will focus on the Guidance for Industry and discuss the most important elements of this part of the regulations.

CEU Credits: 0.1

Course Code: ELM-116

Duration: 20 mins

Skill Level: Advanced

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.2

Effective Date: 03/01/2023

Curriculum for this course

Introduction

Overview

Learning objectives

Who should take this course?

Course modules

21 CFR Part 11 - 2003 Guidance

Issues with Part 11

Application and Enforcement Discretion

Application – Part 1

Application – Part 2

What Specific Electronic Records are in Scope of Part 11?

Out of Scope – Records and Signatures

Enforcement Discretion - Overview

Enforcement Discretion – Validation

Enforcement Discretion – Audit Trail

Enforcement Discretion – Legacy Systems

Enforcement Discretion – Copies of Records

Enforcement Discretion – Record Retention

Final Guidance Summary

21 CFR Part 11 Resources and Guidance from the FDA

Conclusion

Final Exam

Certification

Revision History

Minor update: Course updated to remove references of prerequisite courses that no longer apply and to update to new navigation standards.

V1.2

Author

Orlando López

E-records Integrity SME

Courses

Browse our extensive catalog of GxP, Corporate Compliance and EH&S training.

Learning Strategy

Boost your organization’s training with LearnGxP’s Learning Strategy Consultants (LSC). They customize learning paths to match your needs, offering ongoing support for lasting success.

Customer Stories

Discover how LearnGxP addresses real challenges, provides effective solutions, and positively impacts our customers’ organizations.