Labelsdesigned, approved, printed and audited in one place.
Most regulated manufacturers run a label tool (NiceLabel, Loftware, BarTender) bolted next to their QMS — versions drift, reprints aren't audited, and 211.122 / 111.130 / 820.120 findings follow. V5 puts the designer, the approval workflow, the print agent and the reprint audit trail in one place — the same place that holds the BMR.
What changes once Label design & print control is live.
Indicative ranges from V5 pilot deployments. Your numbers will land near these once the workflow is operator-led and e-signed at the step.
What changes the day you switch this on.
- Manual, paper-driven, and only audited after the fact.
- Tribal knowledge in spreadsheets and shared drives.
- Wet-ink signatures collected hours after the work happened.
- Errors caught at month-end — too late to fix the batch.
- Drag-and-drop, mm-calibrated
- Designed with AI, tweaked with AI
- Independent-reviewer e-signature
- Element-level version diff
What you actually get
Operator-led, e-signed, immutable. Engineered for regulated manufacturers — not retrofitted.
Drag-and-drop, mm-calibrated
Text, shapes, barcodes (Code 128, GS1-128, QR, DataMatrix), allergen/GHS icons, Nutrition Facts panels (food only) and merge fields like {{lot.number}}, {{lot.expiry}}, {{ship_to.city_zip}}.
Designed with AI, tweaked with AI
Describe the label in plain English and the assistant returns a fully laid-out draft. Then say 'make the barcode bigger' or 'swap to QR' and it rewrites in place — every change logged.
Independent-reviewer e-signature
Approve & lock requires a second e-signature per 21 CFR 211.186 / 111.205 — same-person approvals are rejected. Clone to draft makes v+1; the previous version stays immutable.
Element-level version diff
Compare any two approved versions side-by-side — added / removed / changed elements highlighted, not just 'something changed'.
ZPL preview + per-printer profiles
Live Labelary preview, raw ZPL side-by-side, saved Zebra profiles (DPI, darkness, speed, tear-off, TT vs DT) auto-prepended on every export and per-template default printer.
Every print captured to the audit trail
Preview, PDF, ZPL export and operator reprint all hit label_print_events with payload hash, operator, WO/lot/shipment/sample context. Test prints flagged separately so production counts stay clean.
One operator action — a complete, signed record.
What it leaves behind
- Part 11 reprint audit trail
- Two-person approval enforced
- Element-level version diff
- Per-template effective dates
The clauses this satisfies
What buyers ask before they switch on Labels.
Keep exploring
MES
Operator-led execution: scan-gated dispense, step-by-step kiosk, equipment + scale integration, live yield. Built for regulated process & discrete manufacturing.
WMS
Receiving, putaway, transfers, cycle counts, picks, pack & ship — all lot-aware, bin-accurate, FEFO/FIFO-enforced and barcode-driven.
QMS
Built-in QMS: deviations, CAPA, supplier scorecards, in-process AQL, release-by-exception. Aligned with 21 CFR 211/820, ISO 13485 and 111.
Got questions, or want to see it on your shop floor?
Ask V5 — our code-aware assistant — or spin up a workspace. Both are free.