By midnight, the corrected configuration passed. The batch was saved—not by writing new code, but by proving that the configured system did exactly what they intended.
“Example four.” She smiled. “We mapped fields between LIMS and ERP—so a ‘pass’ result in LIMS automatically creates a ‘release order’ in ERP. The mapping is configuration. The underlying software doesn’t change.” gamp category 4 examples
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. By midnight, the corrected configuration passed
“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.” “We mapped fields between LIMS and ERP—so a
