21 CFR Part 11

The Fundamentals of Electronics Records and Signatures

Electronic records and signatures are an important part of our personal and professional lives. In this course, learners will explore the definition of electronic records and signatures. They’ll learn the attributes of both, and the lifecycle of electronic records. Learners will also explore the data integrity principles and methods that keep our records and signatures safe.

CEU Credits: 0.1
Course Code: ELM-112
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V2.0
Effective Date: 01/24/2025

Curriculum for this course

Course Introduction
Defining Electronic Records and Signatures
Importance of Electronic Records and Signatures
Regulations
Global Harmonization Trends
Data Integrity Principles
Security Measures
Electronic Records - Overview
Electronic Records Attributes
Lifecycle of Electronic Records
Retention and Archiving
Attributes of Electronic Signatures
Types of Electronic Signatures
Risk Assessment
Compliance Monitoring
Types of Computer Systems
Computer System Validation
CSV and Electronic Records and Signatures
Summary
Test Your Knowledge
v2.0 Major update on 01/24/2025. This course has been redesigned. The redesign includes new learning objectives to align with updated content, as well as a new exam for those objectives. The visual design has been updated as well.
v1.2 Minor update on 09/03/2024 to fix spelling error on slide titled Subpart A – General Provisions: Sec. 11.3 Definitions
v1.1 Minor update on 06/25/2024 to fix section heading and associated audio and update course to modernize course design.
v1.0 Course released on 09/28/2021

Author

Orlando López

E-records Integrity SME

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