GAMP Category 4 refers to configured software —off-the-shelf products that are customized through settings, parameters, or user-defined rules (e.g., ERP systems, LIMS, SCADA, or a laboratory instrument’s configuration). They require validation of the configuration, not the base code.
“Example three,” Lena continued, pulling up a for the filling line. “We configured alarm thresholds for temperature—if the sterilizer drifts above 122°C, pause production. That’s Category 4.” gamp category 4 examples
Just then, the validation script failed on Test ID 47. The configured workflow rule “Retest on OOS” had been set to “2 retests max”—but the system allowed a third. or user-defined rules (e.g.