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 […]
What Is The ROI For Automated Validation Testing?
Independent Verification and Validation (IV&V) is a regulatory imperative for software deployments within the life sciences industry. The FDA provides guidance on what is expected during the validation process and how to conduct due diligence for the validation process. IEEE 1012 is the industry standard for IV&V. This industry standard provides the background, rationale, process, […]
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 […]
