How Do the FDA's CSA Guidance and GAMP 5 Align?
Learn how ISPE's GAMP 5 Guideline and the FDA's CSA Guidance play complementary roles in ensuring the integrity and reliability of computerized systems.
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How Computer Software Assurance Will Impact Traditional CSV Testing
Apr 12, 2023 11:11:23 AM | Computer software assurance (CSA) encourages the use of unscripted test methods, such as ad hoc testing, and automated technologies.
Posts about Computer Software Assurance (CSA) (2):
How Computer Software Assurance Will Impact Traditional CSV Testing
Computer software assurance (CSA) encourages the use of unscripted test methods, such as ad hoc testing, and automated technologies.
Computer Software Assurance (CSA): What's All the Hype?
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.
Transitioning From CSV to CSA
The upcoming transition from CSV to CSA models reduces the cost of validation and provides a more risk and science based approach.
FDA's Computer Software Assurance (CSA) – Part 1 of 3
Traditional computer software validation (CSV) focuses on documentation. Computer software assurance (CSA) focuses on critical thinking.
Critical Thinking and Its Role in Computer Software Assurance (CSA)
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 Assurance (CSA): Focus on Records, Not Documentation
The thinking is the more paper you generate, the better you validate. According to the FDA, this is not only wrong, it's dangerous.
FDAs Computer Software Assurance (CSA) – Part 2 of 3
Changing mindsets from compliance-centric to quality-focused isn’t easy. It’s possibly the most difficult change to make, but it’s necessary for a quality culture to take hold.
Are You Aligned with FDA's Computer Software Assurance Methodology?
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.
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