Computer System Validation – Requirements: The Basis for Validation
Description: Whether you’re developing a system from scratch or purchasing a system, requirements need...
Certified Online Course
Managing and Ensuring Data Integrity of E-Records within a Regulated Environment
Description: This course has been created for anyone who is interested in learning more...
Certified Online Course
Implementing Compliant Systems in the Cloud
Description: In this course, you will learn how to implement compliance systems in a...
Certified Online Course
Laboratory Data Integrity & The Principles of ALCOA
Description: It is critical that the data generated in a regulated laboratory is accurate...
Certified Online Course
Data Integrity & Good Documentation Practices (GDocP)
Description: This course has been designed to help you understand Good Documentation Practices 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...
The 6 Quality Attributes Required to Create Solid User Requirements [Video]
Requirements come in all forms. These can include: Functional requirements Language requirements (you may...
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