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Case Study

Electronic Record Retrieval During FDA Audit

Electronic Record Retrieval During FDA Audit

Electronic Record Retrieval During FDA Audit

42Q
Pages 2 Pages

During an imminent FDA audit, a leading Class II medical device OEM relied on Sanmina, whose eight facilities used 42Q cloud MES to ensure timely, verifiable quality records compliant with FDA QSR. Auditors demanded Device History Records (DHRs) for high-volume devices in specific date ranges and those using particular IC lot codes. The 42Q software instantly generated accurate, complete DHRs with full traceability, eliminating manual searches and delays. Its structured data capture and real-time reporting ensured seamless audit readiness, proving compliance effortlessly and safeguarding production continuity across facilities.

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