Controls for Open IT Systems – 21 CFR Part 11 [Video]
First of all, what is an open system? An open system is where data...
7 Top Tips to Help You Validate Computer Systems [Video]
To help you successfully validate a computer system remember the following: 1. Development Methodology...
Examples of Closed Systems – 21 CFR Part 11 [Video]
Closed Systems are computer systems where system access is controlled by people who are...
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 [Video]
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...
How to Protect Your Electronic Records and Comply with 21 CFR Part 11 [Video]
There must be procedures in place to ensure that data in FDA regulated computer...