CSV and CSA FAQs: Practical Answers for Life Sciences Validation Teams
Get practical answers about CSV, CSA, risk-based testing, assurance needs, documentation, requirements, and ValGenesis support for software validation.
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Sep 24, 2026, 9:00:03 AM | Get practical answers about CSV, CSA, risk-based testing, assurance needs, documentation, requirements, and ValGenesis support for software validation.
Get practical answers about CSV, CSA, risk-based testing, assurance needs, documentation, requirements, and ValGenesis support for software validation.
Learn how Catalent scaled CSV compliance with ValGenesis VLMS to enhance global IT operations.
Learn how traditional CSV conflicts with Agile development principles and why computer software assurance (CSA) is a better fit for Agile environments.
Unlocking the potential of Computer System Assurance (CSA) in pharmaceuticals: A roadmap for a seamless transition from CSV to CSA.
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.
A better resource use, a simpler process, and a superior product quality. These are some of the CSA benefits explored in this blog post.
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.
The upcoming transition from CSV to CSA models reduces the cost of validation and provides a more risk and science based approach.
Quality Risk Management
Finding the Root Cause in mAB Production: a ValGenesis Story
Learn how we helped a customer find the root cause of a problem in monoclonal antibody (mAB) production and become stronger.
Written by
Sofia Santos
Tech Transfer & Process Scale-up
How to Accelerate Process Scale-Up With Effective Tech Transfer
There's a need to accelerate pharma product development and process scale-up. Having an effective tech transfer strategy can help you.
Written by
Sofia Santos
Cleaning Validation
Risk-Based Cleaning Validation: A Lifecycle Approach
Explore the evolution of pharmaceutical cleaning validation from compliance-focused practices to a risk-based, lifecycle-driven approach.
Written by
Kenneth Pierce
CSA flips the paradigm of traditional CSV to "right-size" validation processes. Learn more about the benefits and principles of the CSA approach, which encourages critical thinking and automation.
Get practical answers about CSV, CSA, risk-based testing, assurance needs, documentation, requirements, and ValGenesis support for software validation.
Previously
ValConnect Innovation Day Princeton: A Glimpse into the Digital Future of Life Sciences
Catalent's Journey of Continuous Improvement for CSV Excellence
Learn how digitization offers a consistent way to carry out cleaning validation lifecycle activities, ensuring your methods and procedures are risk-based and rooted in scientific evidence.
Explore practical FAQs on cleaning validation in pharma, including regulatory expectations, limits, lifecycle stages, sampling, change control, and digital execution.
Previously
Dirty and Clean Hold Times: Setting Defensible Limits for Cleaning Validation
Waves of new technology and thinking — IoT, AR, cloud, Agile — are transforming the very foundation of validation processes. Learn how to leverage them in a Pharma 4.0 world.
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