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.
Here’s a short story built around examples (configured software products). Title: The Validation Window
“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.”
Her junior engineer, Tom, nodded. “But if we type 95 instead of 90 by accident…”
Dr. Lena Sarkisian stared at the flashing cursor on her validation report. “If this fails,” she muttered, “the batch gets incinerated.”
Tom frowned. “What about the ERP integration?”
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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.
Here’s a short story built around examples (configured software products). Title: The Validation Window gamp category 4 examples
“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.” Title: The Validation Window “Example four
Her junior engineer, Tom, nodded. “But if we type 95 instead of 90 by accident…” The underlying software doesn’t change
Dr. Lena Sarkisian stared at the flashing cursor on her validation report. “If this fails,” she muttered, “the batch gets incinerated.”
Tom frowned. “What about the ERP integration?”
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