Are you working in pharmaceuticals, medical devices, biotech, or any other regulated industry and wondering how to get started with Computer System Validation (CSV)? You’re not alone. With increasing demand for compliance with GxP regulations and FDA 21 CFR Part 11, learning CSV is a smart career move—whether you’re a quality specialist, IT professional, or system owner.

But here’s the challenge: traditional CSV training is expensive, complex, and time-consuming. Buying the full set of GAMP® 5 guides can cost tons of money, and understanding them without prior experience is not easy.

Fortunately, there’s a better way.

Learn Computer System Validation Online – affordable, practical, and complete

At Axteon, we believe CSV training should be accessible to everyone. That’s why we’ve created online courses on Udemy that cover all key areas of Computer System Validation—from risk-based approaches to data integrity, electronic records, electronic signatures, and audit trail review.

Why choose Udemy courses?

• Much cheaper than GAMP books – GAMP guides are useful—but costly. Our Udemy courses cost a fraction of the price and include lifetime access.
• Easier to understand – We break down complex validation topics into bite-sized, easy-to-follow lessons. Perfect for beginners and professionals alike.
• Covers all major CSV disciplines – Learn everything from validation planning, test documentation, change control, to vendor assessment and periodic review.
• Learn at your own pace – No need to attend expensive workshops or wait for in-person training dates. Our courses are available 24/7.
• Based on real industry practice – The training is designed by professionals with years of hands-on experience in pharmaceutical and life sciences industries.

Available courses on Udemy

Here are the current Udemy courses created by Axteon that you can start today:

• Validation and Maintenance of Computerized Systems – Dive deep into the world of computerized systems validation with this course. Learn the ins and outs of validating and maintaining computerized systems according to the latest GAMP 5 standards, version two.
• Computer System Assurance – Quality Assurance of Computerized Systems – Ensure the highest quality and reliability of your computerized systems with this specialized training. This course covers the essentials of computer system assurance, equipping you with the knowledge and skills you need to excel in this critical area.
• Agile Validation in GxP – Applies to companies developing software for GxP-regulated industries, pharmaceutical companies creating software for internal use, and regulated firms adopting agile methods for software validation.
• Data Integrity for Computerized Systems in GxP – Covers accuracy, reliability, and consistency of data throughout its lifecycle, crucial in sectors like healthcare, finance, and research.
• Qualification of Cloud Infrastructure Based on GAMP – Understand evolving infrastructure models (on-premises, IaaS, PaaS, SaaS) and how to qualify and validate cloud-based systems using providers like AWS, Google, and Microsoft.
• Validation of Mobile Applications – Mobile apps can act as computerized systems or medical devices (SaMD). Learn how to validate them, manage data storage, and assess integration risks.
• Spreadsheet Validation Based on GAMP 5 – Learn how to validate spreadsheets used in GxP environments, focusing on design, risk analysis, and test case development.
• Consideration and Validation of AI & ML GxP Systems – Explore GAMP 5 guidance on AI and ML systems, Good Machine Learning Practices, validation approaches for AI/ML, and ethical use of tools like ChatGPT.
• Auditing GxP Computer Systems for Regulatory Compliance – Covers audit practices aligned with EU Annex 11 and 21 CFR Part 11 to ensure regulatory compliance of GxP computerized systems.

Who should take these courses?

Our CSV training is ideal for:

• QA/RA professionals
• CSV consultants
• IT and automation engineers
• System owners
• Project managers in GxP environments
• Anyone entering the pharmaceutical or medical device industry

Start learning today

Computer System Validation doesn’t have to be confusing or expensive. With our Udemy courses, you can build your skills, grow your career, and stay compliant—without wasting time or money.

👉 Browse the courses above and pick the one that fits your learning path.
Join thousands of professionals worldwide who are already validating systems with confidence.