Electronic Record Retrieval During FDA Audit
FDA auditor praise
one of the best I have seen"
During an FDA audit, the ability to produce correct, clear, and verifiable quality records in a timely manner is essential. Implemented properly, the right MES solution can provide the structure for and ensure compliance with key elements of the FDA QSR (Quality Systems Regulation). A leading OEM of class 2 medical devices had outsourced production of its products to Sanmina, a leading contract manufacturer of medical products. Eight of Sanmina’s medical manufacturing facilities use the 42Q cloud solution. The FDA would be at Sanmina in a few days, and Sanmina knew the FDA was expecting to see:
- DHR’s for the production of high-volume medical devices, built within a certain date range.
- DHR’s for products built using integrated circuits from specific lot codes.
- Test and parametric data for specific products.
- Training records related to a work instruction ECO (Engineering Change Order).
Sanmina has been using 42Q as its MES core for many years in multiple medical manufacturing facilities producing both high-volume medical devices, along with highly complex diagnostic imaging equipment. The implementation has become very mature:
- All electronic DHR’s. DHR’s are “evergreen”, with any product rework or subsequent upgrades or repairs automatically appended to the original electronic DHR.
- The electronic DHR’s have automatic linkages to component lot data for complete electronic traceability.
- Integration with training record databases and software. Operators' badge scan into their workstations, and if they are not trained to the current work instruction revision, they are locked out.
- Automatic upload of test and parametric data, associated with a specific device serial number.
- Full integration with production equipment via API’s (e.g. barcode scanners, label printers, test equipment).
- Multi-plant integration and visibility in the top level DHR: Genealogy, traceability and linkage of sub-assembly DHR’s (e.g. PCBA’s built in other Sanmina plants) to the top system level DHR.
The speed of producing the requested information, along with the quality and consistency of the records resulted in a successful audit. Comments made by the FDA auditor during the closing meeting were highly complementary regarding the implementation and validation of the quality system. Positive comments were also made about the complete “end to end” integration and electronic records made possible with 42Q, from incoming inspection through production, all the way to the shipping dock.
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