An electronic Device History Record (eDHR) is the electronic production record for a medical device, lot or batch — materials, operators, equipment, in-process checks, UDI and signatures. The former DHR section, 21 CFR 820.184, was removed when FDA's Quality Management System Regulation took effect on 2 February 2026; Part 820 now incorporates ISO 13485:2016, which still expects production records for each device or batch. V5 assembles the record 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 (UDI) is a code issued under an FDA-accredited issuing agency's system (GS1, HIBCC or ICCBBA) that combines a Device Identifier (DI) with Production Identifiers such as lot, serial number or expiry date. FDA's UDI Rule (21 CFR Part 830 and the labeling rules in Part 801) requires it on labels and packages in plain-text and machine-readable (AIDC) form, and labelers submit DI data to GUDID. V5 prints UDI labels at the workstation and records them in the device history.
V5 includes industry packs for regulated manufacturers including pharmaceuticals, medical devices, dietary supplements, food processing, meat, bakery, ingredients and dry mixes, produce packing, cosmetics, cannabis, pet food, veterinary pharma, plastics and resins, agricultural chemicals, radiopharmaceuticals, chemicals, blood and tissue, and consumer products. Packs adjust terminology, screens and reports. The industries directory also lists further markets with guidance pages; ask which pack fits yours.
V5's pet food industry pack supports the production records pet food makers keep: formulas, ingredient lots, process and quality checks, lab results, labels and lot traceability, alongside hazard analysis and preventive-control records under FSMA's animal food rule (21 CFR Part 507). Whether guaranteed-analysis or nutrient-profile checks and label verification are set up for your products is confirmed during scoping; your team remains responsible for label claims.
Try V5 with your own records, or ask a question first. Ask V5 opens with an editable question; nothing is sent until you choose to.
