21 CFR Part 11 – 2003 Guidance
Description: This course covers the August 2003, US FDA Guidance for Industry: Part 11,...
Course Code: ELM-116
by: Orlando López
Macro-learning
21 CFR Part 11 – Electronic Signatures
Description: The main objectives of this course are to give learners a grounding in...
Course Code: ELM-115
by: Orlando López
Macro-learning
21 CFR Part 11 – Electronic Records
Description: The main objectives of this course are to give learners a grounding in...
Course Code: ELM-114
by: Orlando López
Macro-learning
21 CFR Part 11 – An Introduction
Description: The main objectives of this course are to give attendees a grounding in...
Course Code: ELM-112
by: Orlando López
Macro-learning
Controls for Open IT Systems – 21 CFR Part 11 [Video]
First of all, what is an open system? An open system is where data...
Course Code: ELM-114
by: Orlando López
Micro-learning
Examples of Closed Systems – 21 CFR Part 11 [Video]
Closed Systems are computer systems where system access is controlled by people who are...
Course Code: ELM-115
by: Orlando López
Micro-learning
Data Integrity – Records Vs Data [Video]
A record is a “snapshot” at a particular time for a particular purpose whereas...
Course Code: ELM-114
by: Orlando López
Micro-learning
Your 1 Minute Guide to Key Regulations Associated with Computer Systems [Video]
By definition, electronic records (and data maintained electronically) are at least managed by a...
Course Code: ELM-125
by: Orlando López
Micro-learning
The Difference Between Data Backup, Recovery, Archiving and Disaster Recovery [Video]
In this article we will discover the difference between: Data Backup Data Recovery Data...
Course Code: ELM-114
by: Orlando López
Micro-learning
The 4 Pillars of a Robust CSV Process [Video]
The overall CSV process must take the following four criteria into account: 1. Regulatory...
Course Code: ELM-114
by: Orlando López
Micro-learning
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