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.
Dr. Lena Sarkisian stared at the flashing cursor on her validation report. “If this fails,” she muttered, “the batch gets incinerated.” gamp category 4 examples
“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.” or user-defined rules (e.g.
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. ” she muttered