{"version":1,"type":"rich","provider_name":"Libsyn","provider_url":"https:\/\/www.libsyn.com","height":90,"width":600,"title":"Episode 65 - From CSV to CSA: Rethinking Validation in the Age of AI with Niyati Patel","description":"Welcome to Automating Quality, the life sciences\u2013focused show exploring how quality, risk, and technology intersect to modernize regulated environments. In this episode, Mandy and Philippe are joined by Niyati Patel, Strategic Quality and Compliance Advisor with 20+ years of experience across pharma, biotech, medtech, and regulated digital implementations. Niyati specializes in the intersection of quality, validation, and digital transformation. Together, they unpack how validation is evolving in the transition from Computer System Validation (CSV) to Computer Software Assurance (CSA). The discussion challenges common misconceptions, emphasizing that the real shift is toward risk-based thinking, lifecycle control, and deeper system understanding rather than documentation-heavy compliance. The conversation then moves into AI. Niyati outlines how organizations should rethink validation frameworks to focus on boundaries, governance, and human oversight, positioning AI as decision support rather than decision-making. Through practical examples and real-world use cases, this episode sets the foundation for understanding how quality leaders can responsibly adopt AI while maintaining compliance, control, and trust. &amp;nbsp; Key Takeaways   01:09: Introducing today's topic  03:24: Niyati\u2019s background  05:43: What is CSV (and its limitations)  09:06: What CSA actually changes  10:41: Validation rigor is NOT reduced  14:00 Why AI breaks traditional validation  16:23: Why AI must be used for decision support, not autonomous decision making  19:13: Example of AI validation framework  23:40: What validation now proves  Please contact us at solabs-podcast@solabs.com if you have questions or comments. Mandy Gervasio Niyati Patel Philippe Gaudreau ","author_name":"Automating Quality","author_url":"https:\/\/docs.solabs.com\/hc\/en-us\/sections\/360006683193-Automating-Quality-Podcast","html":"<iframe title=\"Libsyn Player\" style=\"border: none\" src=\"\/\/html5-player.libsyn.com\/embed\/episode\/id\/40749970\/height\/90\/theme\/custom\/thumbnail\/yes\/direction\/forward\/render-playlist\/no\/custom-color\/88AA3C\/\" height=\"90\" width=\"600\" scrolling=\"no\"  allowfullscreen webkitallowfullscreen mozallowfullscreen oallowfullscreen msallowfullscreen><\/iframe>","thumbnail_url":"https:\/\/assets.libsyn.com\/secure\/item\/40749970"}