Gamp | Software Categories
GAMP software categories provide an essential risk-based tool for validating computerized systems in regulated environments. By correctly classifying software as Infrastructure (Cat 1), Non-Configurable (Cat 3), Configurable (Cat 4), or Custom (Cat 5), organizations can focus validation efforts where risk is highest—primarily on configuration errors and custom code. This approach not only ensures regulatory compliance but also reduces validation lifecycle costs and accelerates time-to-market. As systems grow more complex (e.g., AI, cloud, continuous integration), the GAMP framework continues to evolve, but its categorical logic remains a cornerstone of computer system validation.
GAMP 5, published by ISPE, is the global standard for the validation of automated systems in life sciences. Its core principles: gamp software categories
When documenting your validation plan, follow this decision tree: As systems grow more complex (e