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
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...
Software Configuration in a Regulated Environment – 1 Minute Guide [Video]
Release documentation needs to contain configuration information to ensure that your installation aligns with...
GAMP®5 Roles and Responsibilities Simplified – Process Owner [Video]
GAMP® 5 defines a set of fairly typical roles in validation. While there’s nothing...
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