CEU Credits: 0.1
Course Code: ELM-114
Duration: 45 mins
Skill Level: Advanced
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.2
Effective Date: 08/11/2021
Curriculum for this course
Overview
Learning Objectives
Who should take this course?
Course Modules
Electronic Records Requirements
Controls for a Closed System – 21 CFR Part 11.10
21 CFR Part 11.10(a) – Computer System Validation (CSV)
21 CFR Part 11.10(a) – CSV Process
21 CFR Part 11.10(a) – CSV Top Tips
21 CFR Part 11.10(a) – CSV Documentation
21 CFR Part 11.10(b) – Accurate and Complete Records
21 CFR Part 11.10(b) – Printable
21 CFR Part 11.10(b) – File Formats
21 CFR Part 11.10(c) – Protection of Records
21 CFR Part 11.10(c) – Data Backup, Recovery, Archiving & Disaster Recovery
21 CFR Part 11.10(d) – Limited System Access
21 CFR Part 11.10(e) – Audit Trails
21 CFR Part 11.10(f) – Operational Checks
21 CFR Part 11.10(g) – Authority Checks
21 CFR Part 11.10(h) – Device Checks
21 CFR Part 11.10(i) – Personnel Qualification
21 CFR Part 11.10(j) – Polices for Using Electronic Signatures
21 CFR Part 11.10(k) – Documentation Controls
21 CFR Part 11.10(k) – Documentation Controls Tips
21 CFR Part 11.30 – Controls for Open Systems
21 CFR Part 11.50 – Signature Manifestation
21 CFR Part 11.50 – Signature / Record Linking
Final Assessment
v1.2 Minor update on 03/04/2025. 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.
v1.0 Course released on 08/11/2021
