Introduction to Computer Systems Validation (CSV)

Computer System Validation is essential in regulated industries because computerized systems must be shown to support user needs, maintain trustworthy data, and operate in a reliable and controlled way. This course introduces the foundations of CSV and explains how validation supports compliance, data integrity, and product quality in the life sciences industry.
You will gain a practical understanding of the core rules and frameworks that guide CSV, with a particular focus on GAMP®5. The course explains key regulations, the Validation V, software categories, validation roles, and the organizational prerequisites that support successful CSV implementation and ongoing control of computerized systems.
The course focuses on key aspects of CSV in practice, including:
    ●  The purpose of CSV and why it matters in regulated industries
    ●  Key regulations and guidelines such as FDA 21 CFR Part 11, Annex 11, and GAMP®5
    ●  The Validation V, software categories, and GAMP5 roles
    ●  CSV prerequisites such as QMS, risk management, deployment practices, and training
Through structured explanations and practical examples, this course helps learners understand how computerized systems are validated and managed within a compliant quality framework. It is best suited to professionals in pharmaceutical, biotechnology, and other regulated environments who need a foundational understanding of CSV and GAMP®5 principles.