V5 Ultimate
Label · Artwork · INCI · Allergen · Warning

AI label & artwork review — catch it in the proof, not in the recall.

V5 compares label and artwork proofs against the approved formula, INCI, allergens, warning statements, net-content, address-of-record and per-market requirements — flagging every deviation before the file goes to the printer.

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The problem

What breaks without this.

Label errors drive recalls

Missing allergen, wrong warning, mis-declared strength — top recall causes across pharma, food and cosmetics.

Review is manual and repetitive

RA proofs every SKU for every market for every revision — with a highlighter.

Studio and RA argue in email

Redlines get lost between the studio, RA and the printer.

How V5 solves it

Records-by-execution. Compliance, by design.

01

Proof compared to the approved formula

Every ingredient, allergen and warning cross-checked automatically.

02

Per-market ruleset

US / EU / UK / Japan / Australia / GCC / LATAM rulesets applied per shipping market.

03

OCR + layout comparison

Text extracted and compared; layout compared against the last-approved version for unauthorised drift.

04

Redlines in the tool, not in email

Studio, RA and printer collaborate on the same proof; every change is versioned and e-signed.

05

Printer-ready gated by RA

PDF/X release is blocked until RA signs; the printer only ever gets the approved file.

Buyer's guide

What to look for when you're buying.

Artwork review tools succeed when they compare against the approved source, per market. Criteria to test.

Formula source of truth

What it tests: Is the proof compared to the approved formula, not a Word doc?

Why it matters: Word docs drift.

V5: Formula-anchored.

Per-market ruleset

What it tests: Are per-market label rules applied?

Why it matters: One-market checks miss the others.

V5: Per-market.

OCR + layout

What it tests: Is layout drift caught, not just text?

Why it matters: Layout drift causes readability failures.

V5: Both.

Version comparison

What it tests: Is the new proof compared to the last-approved?

Why it matters: Unauthorised changes hide in redesigns.

V5: Version comparison native.

Printer-file gate

What it tests: Is PDF/X release blocked until RA signs?

Why it matters: Otherwise the wrong file ships.

V5: Gated.

Collaboration in-tool

What it tests: Are redlines in the tool, not email?

Why it matters: Email loses redlines.

V5: In-tool with versioning.

Compared

Spreadsheet vs legacy QMS vs V5.

AI artwork review vs a proofreader and vs a legacy artwork module.

CapabilitySpreadsheetLegacy QMSV5 Ultimate
Formula anchorWord docSometimesNative
Per-market rulesManualSomeNative
Layout driftEyeRareNative
Version compareManualSometimesNative
Printer gateEmailSometimesGated
Regulatory deep-dive

The clauses, verbatim — and how V5 answers each.

Label clauses across drugs, food, cosmetics and devices.

21 CFR 201
Labeling — drugs.

V5: Drug label rules applied per market of sale.

21 CFR 101
Labeling — food.

V5: Food labelling including allergen call-outs applied.

EU 1169/2011
Food information to consumers.

V5: EU FIC rules applied for EU markets.

EU MDR 2017/745 Annex I §23
Information supplied by the manufacturer.

V5: Device label content and symbols checked per MDR / IVDR.

How it works in V5

Step by step on the floor.

Artwork review goes live in weeks.

  1. 1
    Setup

    Formula and market master aligned

    Approved formulas and intended markets on item master.

  2. 2
    Week 1

    Rulesets loaded

    Per-market rulesets configured.

  3. 3
    Week 2

    Studio onboarded

    Studio uploads proofs; RA reviews in-tool.

  4. 4
    Week 3

    Printer gate on

    Printer file release blocked without RA signoff.

ROI & cost of failure

The math, with the assumptions visible.

ROI is measured in prevented recalls and RA throughput.

Label-driven recalls

Before
Non-zero
With V5
Structurally reduced

Every checked field is one that can't be missed.

RA review time per proof

Before
Hours
With V5
Minutes

AI passes surface only real issues.

Rework cycles printer ↔ studio

Before
3-5
With V5
1-2

Issues caught pre-printer.

One prevented label recall usually pays the module for years.

Customer scenario

What changed on the floor.

Setting

A dietary supplement brand with 60 SKUs across US, EU and CA.

Before

Two recalls in three years on missing allergen call-outs; artwork rework cycles averaged 4.

After

One year on V5, zero label-driven recalls; rework cycles down to 1.5 average; RA time reallocated to submissions.

What you get

Proof points

  • Every ingredient, allergen and warning cross-checked
  • Per-market ruleset applied
  • Layout-drift caught, not just text-drift
  • Printer file gated by RA signoff
Regulatory anchors

Built to satisfy

  • 21 CFR 201 (labeling — drugs)
  • 21 CFR 101 (labeling — food)
  • EU 1169/2011 (food information to consumers)
  • EU 1223/2009 (cosmetics — labeling)
  • EU MDR 2017/745 Annex I §23 (device labeling)

Related on V5

Industries
Modules
Glossary

Frequently asked questions

Does it support translated labels?+

Yes — per-market language variants are handled with per-locale rulesets.

Can it read barcodes?+

Yes — GS1, UDI and lot barcodes are decoded and validated against the intended values.

What formats does it accept?+

PDF, AI, INDD, PNG — extraction runs on any of them; PDF/X is the printer-release format.

See V5 on your own line.

Free trial, no card. Live in 7 days with guided onboarding.

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