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