GAMP categories are a classification system used in the pharmaceutical and life sciences industries to determine the necessary level of validation for computerized systems. Established by the International Society for Pharmaceutical Engineering (ISPE), GAMP (Good Automated Manufacturing Practice) categories allow companies to apply a risk-based approach to compliance, focusing more rigorous testing on complex systems that directly impact patient safety and product quality. What is GAMP 5?

: Requires the highest level of scrutiny. This includes full life-cycle documentation: user requirements, functional specifications, design specifications, and rigorous unit and system testing. Why Categorization Matters

The GAMP categories provide a valuable framework for analyzing and understanding the complex and multifaceted nature of games. By considering games through these different lenses, we can:

Review your current system inventory. If a system labelled "Category 3" has configuration settings, user roles, or workflows, it may actually be Category 4—and your validation may be insufficient.