Tom frowned. “What about the ERP integration?”
“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. gamp category 4 examples
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. Tom frowned
Her junior engineer, Tom, nodded. “But if we type 95 instead of 90 by accident…” They had enabled “record all changes” and configured
Lena sighed. “Document the deviation. Change the config, re-run the test. That’s GAMP Category 4 life.”
Dr. Lena Sarkisian stared at the flashing cursor on her validation report. “If this fails,” she muttered, “the batch gets incinerated.”
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.