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Understanding GAMP Software Categories: A Practical Approach to Risk-Based Validation in Regulated Industries

Before categorizing software, you must determine if it impacts GxP (Good Practice) data. If a system has no impact on patient safety, product quality, or data integrity, it may be designated as non-GxP and require no validation (though this decision must be justified). gamp software categories

GAMP 5, published by ISPE, is the global standard for the validation of automated systems in life sciences. Its core principles: or data integrity