CSV Is Breaking: How CSA & AI Are Reshaping Validation | Bags2Riches X Sreejith K | EP12

Is Computer System Validation (CSV) still fit for today’s fast-moving, cloud- and AI-driven world?

In this episode of Bags2Riches, we dive deep into the shift from CSV to Computer Software Assurance (CSA) and what it truly means for professionals working in pharma, biotech, medical devices, and regulated digital systems.

Sreejith's LinkedIn -   / sreejith-kanhirangadan-csv-advisor  
Courses offered by Sreejith -
1. CSV Gamechanger course
https://csv-gamechanger.xperiencify.i...
2. Udemy course : CSV Career Accelerator 2025: Skills, AI & Career Growth
https://www.udemy.com/course/csv-care...

🎙️ We discuss:

The real difference between CSV and CSA (beyond the buzzwords)

Why traditional validation became overly documentation-heavy

How risk-based thinking is reshaping compliance

What changes when validation responsibility is shared with cloud vendors

Why supplier evaluation is now a core part of quality systems

How AI is entering validation — and the risks and opportunities it brings

The rise of continuous validation in AI-enabled systems

Why human judgment and critical thinking matter more than ever

This conversation isn’t about replacing quality professionals with automation. It’s about how CSA + AI can elevate validation — if we use them thoughtfully.

Whether you’re a validation engineer, quality professional, digital transformation leader, or a student entering life sciences, this episode will help you understand where the industry is heading and how to prepare.

Timestamps-
00:00 Introduction to Computer System Validation
03:01 Transition from CSV to CSA
05:56 Quality Professionals and Shared Risk
09:02 Audit Preparedness in a New Era
11:58 Engaging with Vendors and Startups
14:55 Advice for Small Companies in Advanced Therapies
16:35 The Appeal of Small Companies
17:09 Understanding CSA for Small Businesses
22:25 Clarifying Misconceptions about CSA
25:34 Subjectivity in Risk Assessment
28:54 FDA's Current Thinking on CSA
33:23 Transitioning from CSV to CSA
37:53 AI's Impact on Validation Processes
44:16 Validating AI Systems in the Industry
51:05 Embracing Change in the CSV Industry
57:14 The Importance of Continuous Validation
01:00:44 Human Skills in the Age of AI
01:06:38 The Future of Validation Roles
01:13:39 The Journey of Personal Growth and Learning

👇 Let us know in the comments:
Do you think CSV is evolving—or breaking?

🎧 About Bags2Riches

Bags2Riches is a podcast featuring honest conversations with global professionals, operators, and leaders who’ve built meaningful careers across borders, industries, and technologies.