Gamp Category 4 Examples Instant

“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.”

“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

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

“Exactly. That’s why we test the configuration .” She clicked to the next tab. They had enabled “record all changes” and configured which events triggered an alert. “We mapped fields between LIMS and ERP—so a

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.