Graham O'Keeffe

21 CFR Part 11 A Dummies Guide Part 2 – Sec. 11.2 Implementation

21 CFR Part 11 A Dummies Guide Part 1 – Sec. 11.1 Scope

21 CFR Part 11 & Analytical Equipment Interfaced to a Computer

7 Items to Consider When Implementing Backup and Restore Policies

The Four Types of Validation Used In The Life Sciences

Equipment Installation Qualification – What Should Be In Your Protocol?

Validation Deviations – An Important Part of Any Validation Project

Writing & Executing a Software Validation Protocol: Plain and Simple

Top 22 Reasons Why Risk Assessments are So Difficult?

Validation Master Plans Vs Project Validation Plans