21 CFR Part 11 – 2003 Guidance
Description: This course covers the August 2003, US FDA Guidance for Industry: Part 11,...
Certified Online Course
21 CFR Part 11 – Electronic Signatures
Description: The main objectives of this course are to give learners a grounding in...
Certified Online Course
21 CFR Part 11 – Electronic Records
Description: The main objectives of this course are to give learners a grounding in...
Certified Online Course
21 CFR Part 11 – An Introduction
Description: The main objectives of this course are to give attendees a grounding in...
Certified Online Course
Data Integrity – Records Vs Data [Video]
A record is a “snapshot” at a particular time for a particular purpose whereas...
Your 1 Minute Guide to Key Regulations Associated with Computer Systems
By definition, electronic records (and data maintained electronically) are at least managed by a...
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...
The 4 Pillars of a Robust CSV Process [Video]
The overall CSV process must take the following four criteria into account: 1. Regulatory...
Audit Trails Vs Metadata – 21 CFR Part 11.10(b) [Video]
The term “accurate” means that data is correct, truthful, valid and reliable. The criterion...
Your 1 Minute Guide to the Protection of Records – 21 CFR Part 11.10(c) [Video]
There must be procedures in place to ensure that data in FDA regulated computer...
Loading...