CEU Credits: 0.1
Course Code: ELM-115
Duration: 45 mins
Skill Level: Advanced
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.2
Effective Date: 09/24/2021
Curriculum for this course
Overview
Learning Objectives
Who should take this course?
Course Modules
Electronic Signature Requirements
Electronic Signatures General Requirements – 21 CFR Part 11.100
21 CFR Part 11.100(a) – Unique
21 CFR Part 11.100(b) – Authenticates
21 CFR Part 11.100(c)(1)(2) – Legally Binding
Electronic Signatures Components and Controls – 21 CFR Part 11.200
21 CFR Part 11.200(a)(1)(i)(ii) – Electronic Signatures
21 CFR Part 11.200(a)(2)(3)(b) – Genuine Owners
Electronic Controls for Identification Codes/Passwords – 21 CFR Part 11.300
21 CFR Part 11.300(a) – Uniqueness
21 CFR Part 11.300(b) – Passwords Changed Periodically
21 CFR Part 11.300(c) – Loss Management Procedures
21 CFR Part 11.300(d) – Unauthorized Attempts Detected
21 CFR Part 11.300(e) – Periodic Testing
Electronic Signatures Summarized
Final Assessment
v1.2 Minor update on 03/06/2025. Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v1.1 Minor update on 06/18/2024 to fix section heading and related audio, remove references to course prerequisites that no longer apply and update course to current navigation standards. Exam question update to remove “Check all that apply” option.
v1.0 Course released in 2021
