The Strategic Guide to Computer Systems Validation (CSV) in Life Sciences
In 2025, the FDA issued 470 warning letters; a staggering 99% of these actions cited deficiencies in documentation, records, or written procedures. This 50% increase in enforcement actions compared to the previous fiscal year highlights a critical vulnerability in how many life sciences organizations approach computer systems validation. You’ve likely experienced how traditional, documentation-heavy validation […]
On Demand Webinar – Agile CSA: Unlocking Efficiency in Software Testing for GxP-Regulated Industries
Webinar Overview This webinar provides an in-depth examination of the FDA-endorsed Computer Software Assurance (CSA) framework—a modern, risk-based alternative to conventional CSV. CSA emphasizes critical thinking, product quality, and patient safety over exhaustive documentation and redundant testing. Led by industry expert Fabio Pigossi, this session will give insights on key principles of CSA and demonstrate […]
On Demand Webinar – Boost Efficiency and Quality with CSA and Modern Software Tools
Watch the On Demand Webinar from Astrix and Valgenesis Explore how CSA enhances resource allocation and quality, with modern software tools accelerating the validation process. In this webinar, we will explore the transformative power of Computer Software Assurance (CSA). By adopting a CSA approach, you can achieve remarkable outcomes: optimizing resource allocation while enhancing quality […]
On Demand Webinar – Computer System Validation Best Practices and Navigating Challenges
Any Computer System Validation (CSV) requires significant project planning and team coordination to execute and maintain the validated status. Assumptions can cause an increased number of variances and setbacks at the end of the execution that generates more work. In this webinar, we will walk through validation planning best practices and common issues to help […]