Tom frowned. “What about the ERP integration?”
Her junior engineer, Tom, nodded. “But if we type 95 instead of 90 by accident…” 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.” Tom frowned
Lena sighed. “Document the deviation. Change the config, re-run the test. That’s GAMP Category 4 life.” “We mapped fields between LIMS and ERP—so a
Here’s a short story built around examples (configured software products). Title: The Validation Window
“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.
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.