When a quality problem reaches the market, the first questions are always the same: which lots are affected, where did they go, and what else used the same materials? GMP requires distribution records that allow a batch to be recalled promptly, and regulators expect manufacturers to be able to trace a batch back to its starting materials. On paper or across disconnected systems, answering those questions can take days.
Links recorded along the way
Swat iQua Suite does not rebuild traceability after the event. The links are created as work happens: dispensing links material lots to the batch, the batch links to its intermediates or bulk, packaging links finished-goods lots back to the batch, and each dispatch links a lot to a shipment and a customer. Shipments refuse any finished-goods lot that QA has not released in Batch Release. As a result, forward and backward traceability is one view, starting from any point in the chain.
Running a recall
When a recall is initiated, the system resolves the affected finished-goods lots and the customers who received them. The team records each customer notification — channel, message and time — and logs returns as they come back. Shipped and recovered quantities are reconciled into a recovery percentage, the effectiveness of the recall is checked, and the recall is closed with an e-signature. Closure exports an evidence manifest with SHA-256 checksums, so the record presented to a regulator can be shown to be complete and unchanged.
Customer notifications are sent through your usual channels and recorded in Swat iQua Suite, so the recall file holds the full history.