Lena sighed. “Document the deviation. Change the config, re-run the test. That’s GAMP Category 4 life.”
“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
Here’s a short story built around examples (configured software products). Title: The Validation Window Lena sighed
“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.” That’s GAMP Category 4 life
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.