Risk Management & Computer Systems Validation: The Power Twins
For as long as systems have been validated, risk is an inherent part of the process. Although validation engineers have been drafting risk assessments since the beginning of computer systems validation, many do not understand how crucial this process is to the overall validation process. Risk management and validation go hand-in-hand. The ISPE GAMP 5® […]
Computer Systems Validation As We Know It Is DEAD
Over the past 10 years, the software industry has experienced radical changes. Enterprise applications deployed in the cloud, the Internet of Things (IoT), mobile applications, robotics, artificial intelligence, X-as-a-Service, agile development, cybersecurity challenges and other technology trends force us to rethink strategies for ensuring software quality. For over 40 years, validation practices have not changed […]
How Vulnerable Is Your Validated System Environment?
If you are a validation engineer reading this post, I have a simple question to ask you.. “How vulnerable is your validated systems environment?” Has anyone ever asked you this question? How often do you think about the impact of a cyber threat against your validated computer system? I know… you may be thinking that […]
The True Meaning of Software Quality
As a long-time validation engineer, I often ponder questions such as “what does it mean to achieve software quality and is it sustainable over time?” I ask myself these questions because in today’s systems environments, there are many factors that can impact software quality assurance. Cyber threats are the elephant in the room. Most validation […]