The Fundamentals of Computer System Validation

Whether you are configuring a new system or making a change in a validated system (e.g., upgrades, patches), CSV processes are based on applicable regulations and guidance, best practices for the industry, and the characteristics of the system being validated.

This course is designed to give you a high-level understanding of applicable regulations, the benefits of using a CSV process, the non-compliance risks, scope, and applicability to various systems utilized in the life sciences industry.

Computer System Validation generally comprises both computer hardware as well as computer software. Not everyone at a company plays a direct role in CSV processes, but support from many different areas is required for successful implementation.

For this reason, it’s crucial to understand what entails CSV processes, why it’s so important and how various roles impact regulatory compliance.