Case Study: Sanmina achieves rapid FDA audit record retrieval with 42Q

Electronic Record Retrieval During FDA Audit

The customer, Sanmina, a contract manufacturer for medical products, faced the challenge of preparing for an imminent FDA audit. They needed to rapidly produce specific, verifiable quality records, including device history records (DHRs) and test data, for class II and class III medical devices. To meet this challenge, they relied on the 42Q cloud-based MES solution already in use across several of their facilities.

The 42Q solution provided Sanmina with instantaneous electronic retrieval of all requested records, thanks to its mature implementation and deep integration with production and training systems. The quality and speed of the delivered information led to a highly successful audit, with the FDA auditor explicitly praising the eDHR implementation as "one of the best I have seen" and commending the end-to-end electronic record system.

Sanmina