Regulated Manufacturers

You build medical, aerospace, defense, or space electronics, and you answer to auditors. Every unit must trace to the lots it used, and every lot to its source. PartsBox tracks stock by lot, serializes the units you build, captures incoming inspection and certificates, and helps with ISO 13485, AS9100, ISO 9001, or 21 CFR Part 11.

What usually goes wrong

Traceability lives in a binder and a spreadsheet, rebuilt by hand before each audit. A recall means searching months of records to find which units used a suspect lot. Inspection records and certificates are stored apart from the parts they cover, so proving what you received takes as long as proving what you shipped.

How PartsBox helps

Keep reels, cut tape, and batches as separate lots, each with its own quantity, location, cost, and a mark for whether it is usable for production. Set an expiration date on lots whose parts have a shelf life, and PartsBox can keep expired lots out of builds. Quarantine a lot until it passes inspection. Serialize each unit you build. Trace forward, from a lot to every unit that used it, and backward, from a unit to every lot it consumed and the order it came from. Attach the certificate of conformance, the incoming inspection report, the quarantine record, and the test results to the lot as PDF files, so the paperwork stays with the parts it covers.

Lot control is everyday stock accuracy first and audit evidence second. The same records that prove a build to an auditor keep your stock and costs correct day to day, whether or not you carry a formal obligation.

Where to start

Start on Control for lot control, serial numbers, and two-way traceability. Defense and aerospace traceability needs are usually met here. Compliance adds the audit trail, 21 CFR Part 11 features for electronic records, and NIST authentication rules, for teams that must meet those standards.

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