Basics of Computerized System Validation
- A Foundational Course
This foundational course introduces the key principles, regulatory expectations, and lifecycle approach of Computerized System Validation (CSV) in GxP-regulated environments. It is designed to equip learners with the essential knowledge needed to validate systems that support pharmaceutical, biotech, and medical device operations — ensuring data integrity, product quality, and compliance with standards such as 21 CFR Part 11 and EU Annex 11.
Why should I apply for this course?
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Gain a Clear Understanding of CSV Fundamentals
This course breaks down the core principles of Computerized System Validation, making it easy to understand the validation lifecycle, documentation requirements, and regulatory context — even for those with no prior validation experience.
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Learn How to Comply with Global Regulations
Understand how to align your validation efforts with regulatory standards such as 21 CFR Part 11, EU Annex 11, and GAMP 5, helping your organization stay compliant and audit-ready.
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Build a Strong Foundation for Career Growth
Whether you’re in QA, IT, validation, or regulatory affairs, this course gives you a recognized baseline of knowledge that opens the door to more advanced roles in CSV, digital validation, and compliance management.
