“Those who succeed don’t sit around making to-do lists – they create actionable plans with clearly defined outcomes and conquer them. When you know what you want, why you want it, and understand how to make your goal a reality, you’ll become a master of time management and take control of the situation.” – Tony Robbins, Inspirational Speaker Beginning an article on software testing with a quote from Tony Robbins might seem bizarre.

Over the years, we have seen a steady increase in companies moving away from paper-based validation to electronic-based approaches after the FDA introduced 21 CFR Part 11, which addresses the use and control of electronic signatures and electronic records. When utilized correctly, 21 CFR Part 11 opens the door to numerous potential process and solution improvements in computer systems validation, yet many teams have failed to take full advantage of these improvements.