V5 Ultimate
Module · Labels

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.

Start free — no card
Every glyph maps to a regulation

Watch a label build itself — by the book.

Nine layers, nine citations. None of them are hand-typed. None of them can be printed against the wrong batch.

NDC 83271-015-60DIETARY SUPPLEMENT
VITA-D3
Cholecalciferol 1,000 IU · 60 tablets · oral
Supplement Facts
Serving Size: 1 Tablet · Servings Per Container: 60
Amount Per Serving
% DV
Calories
5
Vitamin D (Cholecalciferol)
25 mcg
125%
Vitamin B6 (Pyridoxine HCl)
2 mg
118%
Vitamin B12 (Cyanocobalamin)
6 mcg
250%
Zinc (as Zinc Oxide)
15 mg
136%
OTHER INGREDIENTS: Microcrystalline Cellulose, Dicalcium Phosphate, Croscarmellose Sodium, Stearic Acid, Silicone Dioxide, Magnesium Stearate.
CONTAINS: Soy lecithin.
LOT
K228
EXP
2026-11
MFG
2025-05
USDA
ORGANIC
NON
GMO
GLUTEN
FREE
NSF
cGMP
VEGAN
GS1-128
(01)00832710150606(17)261130(10)K228(21)9477
UPC-A
0 83271 01506 6
DSCSA · DM
MANUFACTURED FOR:
VitaHealth Solutions, LLC · 123 Wellness Way, Austin TX 78701
WO-24-0918 · LINE-B-02✓ signed · sha256 c91…7e2
layer 1 of 9
Layout & branding
Brand pack · approved master

Layout is a controlled artifact — version-controlled, e-sig approved, never a Word doc.

21 CFR Part 11 · §11.10 — §11.300

A label isn’t artwork.It’s a regulated record.

Most label tools are design studios — they let you draw a label and push it to a printer. Part 11 doesn’t care about drawing. It cares about who approved that layout, which batch it was bound to, who actually pressed print, and whether anyone could quietly change it after the fact. V5 holds the label as a record, not a file.

11
§11.10 controls satisfied at the label level
100%
Print events e-signed + hash-chained
0
Edits possible after release without a new rev
14s
Median time to retrieve any historical print
New · Capture-to-Clone

Take a photo of any label.Get a signed master in seconds.

Onboarding a new SKU used to mean re-keying a label by hand from a PDF or a vendor sample. Open V5 on a phone, point it at the existing label, and the engine extracts every regulated field — identity, NDC, lot pattern, barcode symbology, allergens, address blocks — and drops them into a draft master ready for QA review.

Kiosk · iPhone · rear cam
NDC 83271-015-60
VITA-D3
1,000 IU · 60 SOFTGELS
SUPPLEMENT FACTS
%DV
Vitamin D3 25mcg
125%
Vitamin B6 2mg
118%
Zinc 15mg
136%
LOT L-24-0918-A · EXP 2027-09
framing
~14s
photo → draft
8 / 8
regulated fields
0
keystrokes
vision-extract · trace e7f3
live
Field map — auto-classified, pre-validated.

Every captured token is matched against the regulated field dictionary, validated for format, and staged in a draft. Nothing is bindable until QA signs the master under §11.50.

productVITA-D3 1,000 IU
ndc83271-015-60
net qty60 softgels
lotL-24-0918-A
exp2027-09
barcodeGS1-128 · (01)(17)(10)
allergensSoy · Gelatin
mfr addressAurora, IL 60504
Drafts, not shortcuts. Capture-to-clone produces a v0.1 draft — the same Part 11 lifecycle still applies. QA still reviews. QA still signs. Vision saves the typing, not the controls.
iOS + Android · works offline at the kiosk
§11.10 — line by line

Every Part 11 control, mapped to the label engine.

Eleven controls. Eleven concrete answers. Click any tile to see the regulation alongside the mechanism that satisfies it.

The label as a record

Seven states. Every transition is signed.

A label master moves through a state machine, not a folder. Each arrow between states is an electronic signature — meaning no rev ever appears without a name, a time, and a reason attached.

e-signature
P. Reyes
QA Mgr · v1.0
signed · §11.50
stage 3 / 7

Released

Second signature releases the master. Now immutable. From here, only supersede — never edit.

The append-only chain

Every print event links to the previous one — by hash.

Each event records its parent’s SHA-256. Change any byte in any historical record and every downstream hash breaks. An auditor with the latest hash can independently re-verify the entire history of a label — without trusting V5.

  • → No silent edits. No quiet reprints.
  • → Reprints carry a reason code, not just a count.
  • → Voids supersede — they never erase.
  • → Chain root + leaf hash exportable for offline archive.
label_id · LBL-VITA-D3
● chain intact
  1. 2025-09-14 14:22:08PRINT
    sha256: c91a4f…7e2
    by J. Park
    rev v1.0
    lot K228
    reason —
  2. 2025-09-14 14:22:34REPRINT
    sha256: b4d109…91a
    by J. Park
    rev v1.0
    lot K228
    reason PAPER_JAM
  3. 2025-09-14 14:23:01REPRINT
    sha256: 7af602…cc8
    by J. Park
    rev v1.0
    lot K228
    reason PAPER_JAM
  4. 2025-09-14 14:23:55VOID
    sha256: 1e8b27…334
    by P. Reyes
    rev v1.0
    lot K228
    reason REPRINT_SUPERSEDES
  5. 2025-09-22 09:12:40SUPERSEDE
    sha256: ff20a6…aa1
    by QA Mgr
    rev v1.1
    lot —
    reason ALLERGEN_TEXT_UPDATE
↑ each link signed under §11.50 · verifiable offline
Why a design studio can’t do this

NiceLabel, BarTender, Loftware — all great designers. None are record systems.

Design studios were built to make a label look right. V5 was built to prove a label was right — at 14:22 on a Tuesday, on the printer in line B, for lot K228, against rev v1.0 of an artwork two people signed off. That’s a different class of system.

capability
Label design studio
V5 label engine
Drawing a label
✓
✓
Push to a thermal printer
✓
✓
Versioned, e-sig approved master
✗
✓
Two-person release per §11.200
✗
✓
Print event signed at the kiosk
✗
✓
Reprint with reason code (no silent reprint)
✗
✓
Hash-chained print history
✗
✓
Bound to the live WO + lot at print time
✗
✓
Training-gated print (rev awareness)
✗
✓
Auditor-readable 10–20 year archive
✗
✓

Designers can be wired up to a record system — but every plumb job becomes one more validated boundary. V5 collapses the boundary by owning the master, the WO bind, the kiosk signature, and the archive in one Part 11–scoped tenant.

The audit moment

“Show me the label you printed at 14:22 on 14 September, for WO-2918.”

✗ paper / design studio
  • 1. Pull the batch record binder from the archive.
  • 2. Find the printer log for line B that shift.
  • 3. Try to match the timestamp to a label image — there isn’t one.
  • 4. Ask the operator who printed (they don’t remember).
  • 5. Cross-reference the supervisor’s sign-off page.
  • 6. Photocopy the saved sample label from the QC drawer.
  • 7. Hand the auditor a stack of paper.
elapsed: 35–60 minutes · confidence: low
✓ V5 — auditor view
$ v5 label.history --wo WO-2918 --at "2025-09-14T14:22:00Z"
event PRINT · rev v1.0 · lot K228
signer J. Park · kiosk LINE-B-02
hash c91a4f…7e2 · chain intact
attachments:
• label_K228_140922.pdf
• zpl_stream.txt
• epcis_event.xml
• signature_envelope.json
elapsed: ~14 seconds · confidence: cryptographic

Stop printing labels.Start signing records.

V5 holds your label library, your print events, and your auditor’s evidence in one Part 11–scoped system — no integrations, no bolt-ons, no quiet reprints.

Start free — no card