ValGenesis Blog
CSA is achievable under current regulation. If you’re following these 3 core CSV principles, odds are you’re already aligned with the new CSA methodology.
Is CSA the new CSV? Not exactly. Here's your comprehensive guide to computer software assurance, the FDA's new framework for validating software systems.
The thinking is the more paper you generate, the better you validate. According to the FDA, this is not only wrong, it's dangerous.
Computer software assurance (CSA) encourages the use of unscripted test methods, such as ad hoc testing, and automated technologies.
CSA prioritizes assurance needs after critical thinking. Here's what you need to address during this crucial part of the methodology.
Critical thinking is a vital life skill and the principal requirement of CSA. Are you a critical thinker? Read on to find out.
Computer software validation (CSV) and computer software assurance (CSA) aren't all that different. So then, what's all the hype about? Let's discuss.
Knowing the ValGenesis VLMS ensures controls and standards are followed according to customer-specific requirements gives stakeholders a high degree of assurance that quality is ingrained in the process.
Changing mindsets from compliance-centric to quality-focused isn’t easy, but it’s necessary for a quality culture to take hold.
Traditional computer software validation (CSV) focuses on documentation. Computer software assurance (CSA) focuses on critical thinking.
