V5 Ultimate
The world's first regime-aware QXS

One platform. Total control. Audit-ready by default.

Every batch built right. True costs in your P&L. Audit packet builds itself.

Free trial. No card. Onboard in days, not months.

Beat 1 · A day on the floor

Receive. Make. Control. Ship. Prove it.

One loop, every regulated maker. V5 runs it end-to-end on your hardware and ERP. Pick yours.

SCAN · PO-24-1188
Match · Lactose monohydrate
LOT 24A-7731 · 25 kg × 8 · CoA attached
EXP
2027-04
QUARANTINE
QA-12
PUTAWAY
RM·B-04
Step 01 · Receive

Goods land. V5 already knows what's coming.

Scan the pallet against the PO. Docs attach, label prints, stock lands in the right bin.

DISPENSE · Comp 03/07under toleranceon targetover tolerancein tolerance
Live
4.812kg
5.000kg
5.073kg
4.998kg
GO!
tgt 5.000
±1.0%
METTLER PG-5002 · USB · signed by op
Step 02 · Pick & stage

The right stock, the right bin, every time.

Scales, scanners and PLCs do the checking — the wrong material can't reach the line.

WO-2025-0418 · v3 (locked) snapshot
  • 01 · Charge purified water 80 L
  • 02 · Add API · scan + weigh
  • 03 · Mix 35 min @ 220 rpm
  • 04 · IPC pH (5.8 – 6.4)
  • 05 · Hold 20 min
out-of-sequence · blocked
Step 03 · Produce

The recipe is locked. The record fills itself in.

On release, the master snapshots into the job. Every reading and signature writes back live, in sequence.

QC REVIEW · WO-041812 checks
Assay 96.4% — below LSL 98.0
DEV-2025-0042 · routed to QA · CAPA suggested
11 in-spec · auto-released
Step 04 · Quality control

Review by exception. In-spec is already green.

Out-of-spec results open a structured deviation tied to operator, equipment and step. Reviewers see only what needs attention.

SHIP · SO-7740 · Acme Healthready
Pallet PLT-00231
LOT 25B-9907 · 480 units · CoA + pack slip
→ DC-Memphis · DHL 1Z…48F
FORWARD
7 cust
BACK
14 lots
RECALL
< 1 s
Step 05 · Ship

Pick, pack, ship — by lot or by serial.

Every unit knows its lot, customer and date. A recall is one query, not a war room.

AUDIT PACKET · WO-0418 Part 11
  • Batch record (BMR)47 pp
  • Operator e-signatures18 / 18
  • Training matrixcurrent
  • Deviations + CAPA1 closed
  • Certificate of Analysisrendered
hand to auditor · PDF or portal
Step 06 · The audit

The auditor walks in. The packet is already built.

Records, signatures, training, deviations, certificates — rendered from one immutable source.

Beat 2 · What advanced control actually fixes

Compliance is the receipt.
Control is the win.

The audit packet is a free side-effect. Customers buy V5 for what it removes — every shift.

The Pain

Wrong material, wrong batch

Scan-gated dispense rejects any lot that isn't approved, in-spec and in-date.

The Waste

Yield loss & silent giveaway

Live weigh-tolerance bands flag overcharges and feed a yield dashboard per SKU and line.

The Friction

Operators waiting on paperwork

The record builds live — no end-of-batch reconciliation, no QA paper queue.

The Risk

Out-of-sequence steps

The next step only unlocks when the previous gate is signed. Skipping is impossible.

The Lag

Stale, stockout-driven planning

Real consumption posts as stock is used — your ERP sees true on-hand in seconds.

The Debt

Untraceable deviations

Every out-of-tolerance event opens a deviation linked to operator, equipment, lot and step.

Beat 3 · Close the loop

Audit-ready records, flowing to your ERP, suppliers and customers.

One immutable source. Three downstream loops. No double-entry.

BATCH-2841 · Mix stepa14f…7c2eSIGNEDBATCH-2841 · QC releaseb9d2…41aeSIGNEDBATCH-2841 · Shipc3e8…092bSIGNEDwrite · sign · lock — immutable

Compliance loop

Every save signed, witnessed, immutable. Part 11, Annex 11, Part 211, Part 820 — wired in.

ERPV5orders · mastersyields · consumption

ERP loop

Keep your ERP. V5 feeds verified consumption, yields and lots back in seconds.

SupplierSPECCustomerCoA · spec · cert

Supplier & customer loop

Suppliers post CoAs against your spec. Customers self-serve the certificates their auditor asks for.

One record · three loops
Audit trail · live
streaming · part 11 e-signed
12:04:11
Dispense step signed
j.morales (operator)e-signed
12:04:14
Dispense witnessed
k.shah (witness)e-signed
12:31:02
WO advanced to Mix
system
13:50:48
Deviation opened — temp 0.4°C high
j.morales
14:02:09
QC reviewed
r.patel (QA)
14:02:14
Batch released → posted to ERP
r.patel + d.kim (two-sig)released
sha-256 ·
0xA47F·91C2·DE08·7B5A·F19E·26C4·08AA·3D71·B662·E48F·0xA47F·91C2·DE08·7B5A·F19E·26C4·08AA·3D71·B662·E48F·
✓ chain valid
Built for your regulator

Pick your industry.

Grouped by regulator. Each page reads like the regulator's checklist — with the evidence V5 builds for it.

Don't see yours? .
Self-guided onboarding

Live in an afternoon. Onboarding included in your trial.

No sales call to start. Three choices and your workspace is ready — configured to your regulator. Larger rollouts and bespoke validation work may be scoped separately.

01
Pharmaceutical
Medical devices
Food processing
Cosmetics
Cannabis
Plastics & resins
Bakery & confectionery
Pet food
Chemicals
Blood & tissue
Veterinary pharma
Produce packing
Pharmaceutical
Medical devices
Food processing
Cosmetics
Cannabis
Plastics & resins
Bakery & confectionery
Pet food
Chemicals
Blood & tissue
Veterinary pharma
Produce packing
18 sectors

Pick your sector

Choose from 18 regulated industries. V5 loads the right regime, vocabulary and gated workflows.

02
FDA 21 CFR Part 11
EU MDR
FSMA 204
ISO 13485

Pick your standards

FDA, EU MDR, FSMA 204, GFSI, ISO 9001/13485, MoCRA, Part 11 — select what applies, V5 wires the controls.

03
LOT-2026-0814 · Active API
BOM-MIX-204 · Granulation
SUP-7821 · CoA received
WO-90412 · Release pending
LBL-2026-0915 · Pouch label
EQ-MIX-03 · Calibration
LOT-2026-0816 · Excipient
BOM-COAT-118 · Film coat
LOT-2026-0814 · Active API
BOM-MIX-204 · Granulation
SUP-7821 · CoA received
WO-90412 · Release pending
LBL-2026-0915 · Pouch label
EQ-MIX-03 · Calibration
LOT-2026-0816 · Excipient
BOM-COAT-118 · Film coat
importing

Test data or your own

Start in a sandbox with sample batches — or import master data and scan existing labels to seed live.

Start self-guided setup

Stop chasing the audit. Start running the floor.

Pick your industry. Watch the record build itself. No card. Onboard in days.

Start free — no card