21 CFR Part 11 – Electronic Records

Description:

The main objectives of this course are to give learners a grounding in the principles of and latest requirements for Electronic Records and Electronic Signatures (ERES). This online course provides an overview of the FDA requirements with practical examples covering the implementation of those requirements.

Curriculum for this course:
Introduction
Overview 2 mins 10 secs
Learning Objectives 2 mins 15 secs
Who should take this course? 1 min 40 secs
Course Modules 2 min 22 secs
Module 1: Subpart B – Electronic Records
Electronic Records Requirements 1 min 20 secs
Controls for a Closed System – 21 CFR Part 11.10 2 min 03 secs
21 CFR Part 11.10(a) – Computer System Validation (CSV) 1 min 20 secs
21 CFR Part 11.10(a) – CSV Process 1 min 45 secs
21 CFR Part 11.10(a) – CSV Top Tips 2 min 33 secs
21 CFR Part 11.10(a) – CSV Documentation 1 min 55 secs
21 CFR Part 11.10(b) – Accurate and Complete Records 2 min 10 secs
21 CFR Part 11.10(b) – Printable 2 min 15 secs
21 CFR Part 11.10(b) – File Formats 2 min 23 secs
21 CFR Part 11.10(c) – Protection of Records 1 min 40 secs
21 CFR Part 11.10(c) – Data Backup, Recovery, Archiving & Disaster Recovery 2 min 48 secs
21 CFR Part 11.10(d) – Limited System Access 1 min 40 secs
21 CFR Part 11.10(e) – Audit Trails 2 min 01 secs
21 CFR Part 11.10(f) – Operational Checks 1 min 55 secs
21 CFR Part 11.10(g) – Authority Checks 2 min 30 secs
21 CFR Part 11.10(h) – Device Checks 1 min 29 secs
21 CFR Part 11.10(i) – Personnel Qualification 2 min 03 secs
21 CFR Part 11.10(j) – Polices for Using Electronic Signatures 1 min 41 secs
21 CFR Part 11.10(k) – Documentation Controls 1 min 45 secs
21 CFR Part 11.10(k) – Documentation Controls Tips 2 min 10 secs
21 CFR Part 11.30 – Controls for Open Systems 2 min 22 secs
21 CFR Part 11.50 – Signature Manifestation 2 mins 15 secs
21 CFR Part 11.50 – Signature / Record Linking 1 min 40 secs
Conclusion
Final Exam
Certification
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