CEU Credits: 0.1
Course Code: ELM-114
Duration: 45 mins
Skill Level: Advanced
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
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
Conclusion
Final Exam
Minor update: Section heading and related audio fixed, removed references to course prerequisites that no longer apply, and course updated to current navigation standards.
V1.1
