Why Are You Still Generating Validation Test Scripts Manually?

Drafting validation scripts is one of the key activities in a validation exercise designed to provide document evidence that a system performs according to its intended use.  The FDA and other global agencies require objective evidence, usually in the form of screen shots that sequentially capture the target software process, to provide assurance that systems […]

Accelerating Validation in the 21st Century

Each day in companies across the globe, employees are being asked to do more with less.  The mantra of the business community in the 21st century is “accelerating business”.  You see it in marketing and all types of corporate communication.  In the validation world accelerating system implementation, validation and deployment is the cry of every […]

5 Ways to Revive Your CSV Validation Process in 2018

If you are like most veteran validation engineers, you have been conducting validation exercises the same old way.  You have been gathering user requirements, conducting risk assessments, developing test scripts (most often on paper) and delivering validation documentation and due diligence as required by current global regulations. Validation processes have not changed very much over […]

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 […]