Automating Validation Testing: It’s Easier Than You Think
Automated validation testing has been elusive for many in the validation community. There have been many “point solutions” on the market that addressed the creation, management and execution of validation testing. However, what most validation engineers want is TRULY AUTOMATED validation testing that will interrogate an application in a rigorous manner and report results in […]
Can Microsoft Azure Be Validated?
The text book definition of computer systems validation (paraphrased) is “documented evidence that a system performs according to its intended use”. The FDA uses the definition “…Validation is a process of demonstrating, through documented evidence, that <software applications> will consistently produce the results that meets predetermined specifications and quality attributes.” Using the FDA’s definition, one […]
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 […]
Leveraging the NIST Cybersecurity Framework
As a validation engineer, why should you be concerned about Cybersecurity? Good question! Today’s headlines are filled with instances of cyber attacks and data breaches impacting some of the largest corporate systems around. As validation engineers, our job is to confirm software quality and that systems meet their intended use. How can you realistically do […]
