V5 enforces allergen sequencing on shared equipment, blocks campaigns that violate the allergen matrix, requires verified cleaning checks between runs (with TOC/ATP results captured to the record), and prints allergen-correct labels gated on the verified cleaning state.
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.
