Inventory & traceability
KDE
Key Data Element
FSMA 204 — the specific data points you must capture at each tracking event.
Key Data Elements (KDEs) are the specific facts FDA requires you to record at each Critical Tracking Event (CTE) under FSMA 204. For example, at receiving: traceability lot code, quantity/UoM, product description, receiver name and address, ship-from location, ship-date. V5 captures these natively at the kiosk during goods-in, transformation and shipping.