An electronic Device History Record is the complete, signed record of a finished medical device — materials, operators, equipment, in-process checks, UDI and e-signatures — required under 21 CFR 820.184 for every unit a device manufacturer ships. V5 builds it automatically as operators work.
A BMR is the live, signed reproduction of an approved Master Manufacturing Record for one specific batch, required under 21 CFR 211.188. It captures every weighment, in-process check, deviation and signature in sequence so QA can release the batch from a single immutable document.
A Unique Device Identifier (21 CFR 830) is a GS1 DataMatrix that pairs a Device Identifier (GTIN) with a Production Identifier (lot/serial, expiry). V5 generates and prints the UDI at the assembly workstation, validates the encoding, and reconciles it to the FDA GUDID submission.
Pharma, medical devices, dietary supplements, food processing, sausage & meat, bakery & confectionery, ingredients & dry mixes, produce packing, cosmetics, cannabis, pet food, veterinary pharma, plastics & resins, agricultural chemicals, radiopharmaceuticals, chemicals, blood & tissue, and consumer products. Each ships with its regulator-specific terminology, records and gates.
Yes. V5 ships AAFCO guaranteed-analysis controls, label-claim verification at release, FDA CVM nutrient profile checks, and FSMA preventive controls for animal food (21 CFR 507). The batch record carries the analytical CoA against the claimed analysis automatically.
