Case Study: Sanmina achieves rapid FDA audit readiness with 42Q MES

Sanmina delivers FDA eDHR records in minutes with 42Q

Sanmina, a leading contract manufacturer for medical products, faced the challenge of preparing for an imminent FDA audit. The agency required rapid retrieval of specific Device History Records (DHRs), test data, and training records for high-volume medical devices. To meet this stringent compliance requirement across multiple facilities, Sanmina relied on its established MES core, the 42Q cloud-based manufacturing execution system.

The 42Q solution enabled Sanmina to instantly produce all requested electronic records with complete traceability and integration. The quality, speed, and consistency of the records delivered during the audit led to a highly successful outcome. The FDA auditor specifically praised the eDHR implementation as "one of the best I have seen," commending the end-to-end electronic integration made possible by 42Q.

Sanmina