V5 Ultimate
The platform

One platform. Every module. One page.

V5 Ultimate is a single, unified manufacturing and quality platform — not a suite of stitched-together apps. Below is everything it does, in the order it does it: run the floor, close the quality loop, control documents, manage materials, prove every batch, extend your stack, and see the floor.

01 — Run the floor

Shop-floor execution

A locked-down, touch-first kiosk for operators — multilingual, offline-tolerant, gloves-friendly and signed at every step.

Line 3 · Kiosk K-07·Op: A. Patel
WO-24871 · 14:32:09
Step 3 of 7 · Dispense

Add Citric Acid — Anhydrous

Lot CA-118-B
Target 24.30 g · Tolerance ±2%
Live Scale · SC-204▼ Under target Within tolerance▲ Over target
08.4214.9119.7822.6423.5824.2724.3124.2924.3224.3024.5124.6924.8624.78g
23.8124.30 target24.79
Signed A. Patel · 14:32:11 UTC
Line 3 · Kiosk K-07·Op: A. Patel
WO-24871 · 14:34:18
Step 1 of 5 · Directed pick

Pick from A-12-03

Stage 7
Scan license plate to confirm — mixed-pallet allowed
License plate Awaiting scan Verified
LP-•••••••LP-887-02
  • Pallet LP-887-02 · 4 × 25 kg sacksscanning
  • Pallet LP-887-03 · 4 × 25 kg sacksqueued
  • Pallet LP-887-04 · 2 × 25 kg sacksqueued
Signed A. Patel · 14:32:11 UTC
Line 3 · Kiosk K-07·Op: A. Patel
WO-24871 · 14:41:02
Step 5 of 7 · In-process check

Tablet hardness

USP <1217>
Spec 7.5 – 9.5 kp · 5 readings required
#18.2
#28.4
#38.1
#48.3
#58.5
Mean vs specCapturing… Pass
7.07.5 LSL9.5 USL10.0
Signed A. Patel · 14:32:11 UTC
Line 3 · Kiosk K-07·Op: A. Patel
INV-MV-1042 · 14:46:30
Inventory · Move

Quarantine lot CA-118-B

LP-887-02
From A-12-03 QA-HOLD-04
Lot status
Released
Quarantined
Reason
Sampling failure — OOS hardness
Disposition
Pending QA review
Linked NCR
NCR-4471
Witness
J. Okafor
  • A-12-03 → QA-HOLD-04
  • System lock placed on lot
  • NCR-4471 auto-opened
Signed A. Patel · 14:32:11 UTC
Line 3 · Kiosk K-07·Op: A. Patel
EQ-SC-204 · 14:50:11
Equipment · Calibration

Scale SC-204 — out of calibration

PM-2117
Recording is blocked until recalibration is signed off.
Tool refused: out of calibration

Last cal 2024-11-26 · expired 12 days ago. Operator cannot record measurements against any work order until recalibration is completed and signed.

  • Calibration check — Scale SC-204overdue
  • Lubricate mixer M-08 bearingsdue
  • Replace oven O-03 thermocouplescheduled
Signed A. Patel · 14:32:11 UTC

Kiosk work orders

One device, every shop-floor task. Operators clock onto an order, see the next step, and confirm — every action timestamped and signed.

02 — Close the quality loop

Quality, audit & CAPA

Findings auto-route into deviations, NCRs, CAPAs and training reassignments — auto-linked to the lot, op and kit, e-signed at every step, SLA-tracked, with trend-triggered CAPA. Nothing falls between QA, production and the supplier.

Quality console · QA-2·R. Singh, QA Lead
NCR-DRAFT · 14:32:09
Floor escalation · Raise NCR

OOS hardness on tablet press TP-04

Severity
Minor
Major
Critical
Auto-linked from kiosk context
Description
Reading #3 = 9.8 kp, USL = 9.5 kp.
NCR-4471 opened · routed to QA Lead
Two-tap raise · auto-linked
Quality console · QA-2·R. Singh, QA Lead
CAPA-9912 · 09:14:02
CAPA workflow · NCR-4471 link

Closed-loop investigation

SLA 30d
Investigation
Root cause
Action plan
Effectiveness
Investigation underway
5 of 7 interviews complete · 2 docs pulled
e-signed
Root cause: punch wear
Fishbone → equipment · punch B exceeded 1.2M strokes
e-signed
Action plan signed
Replace punch set · update PM cadence to 800k strokes
e-signed
Effectiveness verified
30-day re-check · 12 lots in spec · CAPA closed
e-signed
Reason-for-change captured
Quality console · QA-2·R. Singh, QA Lead
AUDIT-INT-Q4 · 10:02:44
Internal audit · Q4 prep

Line 3 walkthrough

Score 80%
  • SOP-114 followed at line 3pass
  • Calibration cert current — SC-204fail
  • Operator training in datepass
  • Cleaning record signedpass
  • Environmental log completepending
Finding F-203 raisedCAPA-9913auto-opened
Findings auto-route to CAPA
Quality console · QA-2·R. Singh, QA Lead
LOT-CA-118-B · 11:24:50
Hold · Disposition pending

Lot CA-118-B · 4 200 units

QA-HOLD-04
Release
Within spec
Rework
Re-press at lower force
Scrap
Destroy & log
Justification & links
Hardness 9.8 kp vs USL 9.5 kp — recoverable by lower compression force.
NCR-4471CAPA-9912WO-24871TP-04
Disposition: Rework · signed R. Singh
Two-person e-sig required
Quality console · QA-2·R. Singh, QA Lead
VOC-INBOX · 08:48:17
Voice-of-customer · Trended

Complaints by lot · last 90 days

Threshold ≥ 4
Complaints / week Trending up Threshold tripped
4
  • CMP-2104Hardness — chipped tabletslot CA-118-B
  • CMP-2107Bottle count short by 2lot CA-118-B
  • CMP-2111Label print misalignedlot CA-118-C
CAPA-9914 auto-opened · scope CA-118-*
Trend-triggered · scope: lot CA-118-*

NCR / deviation from the floor

Two-tap creation at the kiosk, linked straight to the affected lot, unit, operator and equipment — nothing falls between production and QA.

03 — Control documents & training

Document & training control

One unified register for internal SOPs and supplier records. Operators are hard-blocked from work they're not currently certified for.

QMS · Doc control·M. Chen, Doc owner
SOP-114 rev 7 · 09:08:42
Approval chain · SOP-114

Tablet press cleaning — rev 7

supersedes rev 6
Two-person sign-off required · reason-for-change captured
Author
M. Chen
Approver A
R. Singh (QA)
Approver B
L. Park (Ops)
Reason for change
CAPA-9912 — tighten cleaning cadence after punch wear finding (rev 6 → rev 7).
+ 3 steps added− 1 step removed~ 2 edited
SOP-114 rev 7 published · 24 training reassigned
Two signatures captured
QMS · Doc control·M. Chen, Doc owner
MATRIX · Line 3 · 09:14:30
Training matrix · Line 3 crew

Role × SOP coverage

4 ops · 4 SOPs
SOP-114
SOP-118
SOP-122
WI-204
A. Patel
J. Okafor
L. Park
K. Vega
Gap on SOP-122 / L. Park — training task auto-assigned, kiosk access revoked until completion.
Re-qualification cadence enforced
QMS · Doc control·M. Chen, Doc owner
WO-24871 · Step 3 · 07:42:11
Kiosk · Step refused

Operator cannot start this step

Op: L. Park
Training out of date for this SOP version

Step requires SOP-122 rev 4. Operator is signed off on rev 3 — superseded 8 days ago.

Resolution path
  • Read SOP-122 rev 4 (delta highlighted)
  • Sign training acknowledgement
  • Kiosk unlock — supervisor witness
Hard block · cannot be overridden by operator
QMS · Doc control·M. Chen, Doc owner
SUPPLIER · Vector · 08:55:09
Supplier document control

Inbound CoAs & certifications

2 suppliers
  • CoA · Citric Acid lot CA-118-B
    Acme Excipients
    expires 312d
  • GMP audit cert
    Acme Excipients
    expires 217d
  • ISO 9001 cert
    Vector Polymers
    expires 27d
  • Material spec MS-104
    Vector Polymers
    expired 4d ago
MS-104 expiredVector Polymersflagged for requalification · receipts blocked
Expiries trigger requalification automatically
QMS · Doc control·M. Chen, Doc owner
CC-2104 · 14:02:18
Change control · CC-2104

Impact assessment cascade

from CAPA-9912
One change, four linked surfaces — nothing is updated in isolation.
  • Documents
    SOP-114, WI-204 — re-issue
  • Training
    24 operators · re-qualification
  • Validation
    OQ §3.2 needs partial re-run
  • Equipment
    TP-04 PM cadence: 1.2M → 800k
All four surfaces linked & versioned

Document register

Hybrid numbering, version control, retention schedules, periodic-review reminders — one unified register for internal SOPs and supplier records.

04 — Materials & batch

Materials, formulas & genealogy

From inbound receipt and identity testing through finished-goods release, with full forward/backward traceability.

Materials · WH-1·M. Alvarez, Materials
RCV-2841 · 08:12:44
Inbound goods receipt
PO-44182 · Whey Isolate 80%
Lot
WI-4471-A
Supplier
NorthPeak
Qty
1,200 kg
Identity test plan
  • FT-NIR fingerprintPass
  • Loss on drying ≤ 5.0%Pass
  • Protein (Kjeldahl) ≥ 78%Pass
  • Heavy metals panelRunning
Quarantine. Lot blocked from BoM consumption until QA release.
Auto-routed · QA queue
Materials · WH-1·M. Alvarez, Materials
MBR-LIB · 08:14:22
Master formula library
Whey-Choc-2lb · MBR-118
Rev 7approved2026-04-12Current
Rev 6superseded2025-11-03
Rev 5superseded2025-06-19
Rev 8draftAuthor: J. Park
Immutable. Approved revisions cannot be edited — only superseded by a new revision.
Frozen at WO creation
Materials · WH-1·R. Singh, QA
GEN-LOOKUP · 08:16:01
Backward genealogy
FG Lot WC-2026-118-A → up the tree
FG · Whey-Choc-2lb · WC-2026-118-A1,842 units
Bulk batch · BLK-118-A1,210 kg
Whey isolate · WI-4471-ANorthPeak780 kg
Cocoa powder · CP-2238CocoaCorp180 kg
Stevia ext · SE-901GreenLeaf12 kg
Bottle · BTL-2lb-KPackPro1,900 ea
Trace runtime0.42 s
Recall-ready · CSV / PDF
Materials · WH-1·K. Wong, Pack
SERIAL · 08:17:33
Serialization & aggregation
WO-44511 · pack line 3
GTIN
0 0863 1244 0118 7
Lot / Exp
WC-118-A / 2028-04
Hierarchycommissioned
Pallet SSCC-0021938448 cases
Case SSCC-0021938524 units
Unit SN-00114471 … 00114494serialized
DSCSA-ready EPCIS event queuedv1.2
EPCIS · sent to TP
Materials · WH-1·R. Singh, QA
LBL-RECON · 08:19:08
Label-claim reconciliation
Per-serving panel vs computed batch
NutrientLabelComputedΔ
Protein25 g25.4 g+1.6%
Carbs3 g2.8 g−6.7%
Sugar1 g0.9 g−10%
Sodium60 mg72 mg+20%
Calcium150 mg152 mg+1.3%
Sodium out of tolerance. Triggers label review & deviation.
Auto-linked to lot WC-118-A

Frozen formula snapshot at release

The batch record is an accurate reproduction of the master at the time of release — not a live re-render, not editable after the fact.

05 — Prove every batch

Compliance & records

21 CFR Part 11 e-signatures on every critical action. ALCOA+ data integrity. Reports follow your industry's terminology.

Compliance · Site 1·QA · Compliance
BR-LOT-118-A · 09:02:14
Batch record · industry-shaped
BMR
Pharma
DHR
Devices
BPR
Supplements
BR
Food
Sections rendered
  • Master formula snapshot (Rev 7)
  • In-process controls — 12 checks signed
  • Material reconciliation (theo. vs actual)
  • Deviations · 2 closed, all e-signed
  • QA release statement & CoA
Enginesingle record schema · sector view
Per-sector terminology
Compliance · Site 1·R. Singh, QA Lead
E-SIG · 09:04:01
21 CFR Part 11 e-signature
QA release · Lot WC-118-A
User ID
r.singh@plant
Role
QA Lead
Action
Release lot for shipment
Meaning
I approve release
Password
••••••••••
Reason for action
QA review complete
Two-factor verified · biometric + password · session uniquely attributed
Authenticated
Attributable
Non-repudiable
Recorded to audit trail
Compliance · Site 1·QA · Compliance
AUDIT-TRAIL · 09:05:44
Immutable audit trail
Lot WC-118-A · last 5 events
ALCOA+
09:03:58r.singhReleased lot WC-118-AQA review complete
08:51:22j.parkEdited SOP-2104 Rev 7 → Rev 8 draftAnnual review
08:48:11m.alvarezQuarantined lot WI-4471-APending heavy-metals
08:32:09k.wongStarted WO-44511Production schedule
08:30:00systemSnapshot MBR Rev 7 → WO-44511Auto
Cryptographically chained. No edits, no deletes — only superseding events.
Reason-for-change · attributed
Compliance · Site 1·QA · Compliance
EXPORTS · 09:07:12
Regulator-ready exports
Pre-shaped per sector — no integration project
DSCSA
EPCIS 1.2 events · serialized
US
FSMA 204
Traceability lot codes · KDE/CTE
US
GUDID / EUDAMED
UDI registry submission
US / EU
USDA FSIS
Form 6500-2 · process verification
US
EU FIR 1169
Nutrition declaration + allergens
EU
Auto-shaped per industry
Compliance · Site 1·QA · Compliance
VAL-PACK · 09:09:21
Validation pack
Shipped with the platform — not a services project
IQ
Installation Qualification
2025-09-12
approved
OQ
Operational Qualification
2025-10-02
approved
PQ
Performance Qualification
2025-10-21
approved
VSR
Validation Summary Report
2025-11-04
approved
ATR
Audit-Trail Review SOP & evidence
monthly
current
Periodic review auto-scheduled · evidence collected into the pack.
GxP audit-ready

Data integrity controls

Time sync, system-clock protection, user-action attribution and no-orphan-record enforcement — ALCOA+ by construction, not by convention.

06 — Extend your stack

Integrations & APIs

V5 sits beneath your existing ERP and pushes verified production data back. Finance and purchasing stay where they are.

Integrations · Platform·IT · admin view
ERP-BRIDGE · 10:02:11
ERP bridge · live
V5 ↔ NetSuite
V5 Ultimate
Verified production
2-way
NetSuite
Finance & purchasing
Sales orders · purchase orders14 today
WO completions · GR/IR · lot postings42 events
Inventory adjustments (scrap, rework)3 events
Item master sync2,140 items
Healthy · last sync 12s ago · queue depth 0
Field-level mappings shipped
Integrations · Platform·IT · admin view
API · v1 · 10:04:32
REST API & webhooks
Modern, tenant-scoped, audited
Endpoints
  • GET /api/v1/lots
  • GET /api/v1/work-orders/:id
  • POST /api/v1/deviations
  • POST /api/v1/lots/release
Webhook events
  • • lot.released
  • • deviation.opened
  • • capa.closed
  • • supplier.qualified
POST /api/v1/deviations
{ "lot": "WC-118-A", "type": "OOS", "severity": 2 }
→ 201 Created · dev-7741
OAuth2 · scoped tokens
Integrations · Platform·IT · admin view
IOT-STREAMS · 10:06:18
Process streams · live
WO-44511 · pasteurizer line
Probe T-101 · HTST hold72.0 °C ± 1.574.2 °C
Probe T-102 · cool-down≤ 7 °C6.8 °C
Scale S-203 · bulk fill118 ± 0.5118.4 kg
Oven O-1 · dwell12.0 min11.8 min
Streamed to batch record42 samples/min · OPC-UA
Auto-attached · no manual entry
Integrations · Platform·IT · admin view
PRINT-Q · 10:08:04
Label & print
Workstation · WS-Pack-03
Zebra ZT411
SATO CL4NX
Domino V230i
Videojet 1580
Brother TD-4D
Honeywell PX940
Print queue
Case label · 24 eaWC-118-APrinting
Pallet label · 1 eaWC-118-AQueued
Unit label · 1842 eaWC-118-ADone
Each label = audit event
Integrations · Platform·IT · admin view
IDENTITY · 10:09:55
SSO & identity
Federated · SCIM-provisioned
Microsoft Entra ID
SAML 2.0
Okta
OIDC
Google Workspace
OIDC
Ping Identity
SAML 2.0
MFA
Enforced
SCIM
Active
Sessions
1,284 today
MFA enforced on signers. Step-up required for QA release, lot disposition, SOP approval.
Just-in-time provisioning

Carrier & 3PL bridges

Shipment manifests, BoL and ASN out to your customers and 3PL of choice — same engine, no separate logistics module to staff.

07 — AI, validation & deployment

Regime-aware AI, vendor-validated, cloud or air-gapped

Every AI action is scoped to the GxP regime of the record it touches and signed under Part 11. Validation packs ship with the release. The same codebase runs as cloud or fully air-gapped on-prem.

Regime-aware AI
scope: 21 CFR 212
Ask V5
scoped
GMP
21 CFR 210/211
Tissue
21 CFR 1271
Radiopharma
21 CFR 212
Device
21 CFR 820
CGT
1271 / Q5A
Supplement
21 CFR 111
AI ACTION · signed · meaning: triage
sha256 · 8c12…a7f3
Same codebase

Two deployments, one substrate

Cloud
Managed multi-tenant, signed at every step.
Air-gapped on-prem
Same modules, same validation pack, no external network.
identical release cadence
Vendor-validated

IQ / OQ / PQ + GAMP 5 — shipped with the release

  • IQ protocol · environment & install
  • OQ protocol · functional coverage
  • PQ protocol · live tenant evidence
  • GAMP 5 categorisation · per module
  • Validation summary · release-bound
  • Regime-aware AI

    Every AI action is scoped to the GxP regime of the record it touches — GMP, GTP, GVP, 212 and 1271 don't share prompts, evidence or signing scope.

  • Part-11 signed AI actions

    When AI proposes a CAPA classification, deviation triage or review-by-exception decision, the action is captured as a signed, attributable record with meaning of signature.

  • eBR with review-by-exception

    The electronic batch record surfaces only signed exceptions for QA review — the rest of the record is provable because every step was Part-11 born signed.

  • Vendor-validated IQ/OQ/PQ + GAMP 5

    Validation packs are shipped, versioned and traceable to the running tenant — IQ, OQ and PQ protocols, GAMP 5 categorisation and a release-bound validation summary.

  • Cloud + air-gapped on-prem

    The same V5 Ultimate codebase runs as a Lovable Cloud tenant or a fully air-gapped on-prem deployment — no fork, no compliance gap, no separate roadmap.

  • Same codebase, two deployments

    Air-gapped sites get the same modules, the same validation pack and the same release cadence as cloud — the substrate is identical.

08 — See the floor

Insight, AI & operations

Live dashboards, predictive alerts and an AI assistant that knows V5, your industry and your data.

Insight · Plant 1·L. Ortiz, Ops Manager
LIVE-DASH · 11:02:14
Live operations dashboard
Plant 1 · current shift
OEE
84%
+3.2
Yield
97.1%
+0.4
Scrap
1.8%
−0.6
OTIF
96%
+1.1
Throughput · last 8hon plan
Lines running
6 / 7
Deviations open
3
CAPAs SLA
2 due
Drillable to lot, operator, shift
Insight · Plant 1·L. Ortiz, Ops Manager
SCORECARDS · 11:04:11
Supplier scorecards · YTD
Composite score, on-time, QA, open CAPA
SupplierOTIQACAPAScore
NorthPeak (whey)98%99%0
96
CocoaCorp92%94%2
84
GreenLeaf (stevia)88%96%1
82
PackPro (bottles)95%91%3
79
Out of the box. No BI project, no warehouse — these are the same records the floor produced.
Shipped · not configured
Insight · Plant 1·J. Park, QA Manager
ASK V5 · 11:06:33
Ask V5 · grounded in your data
Why did yield drop on Line 3 last Thursday?
Yield on Line 3 dropped 4.1% on Thu 04 Jun, driven by lot WC-118-A. Cool-down probe T-102 ran 1.4 °C above target between 14:02–14:38, triggering 312 units of rework. Operator K. Wong opened deviation DEV-7712. Root cause linked to coolant pump P-4 — PM was due 08 Jun, see WO-MP-318.
DEV-7712Lot WC-118-AWO-MP-318SOP-2104
Ask anything about your batches, lots, suppliers, training…Ask
Cites the actual records
Insight · Plant 1·L. Ortiz, Ops Manager
ALERTS · 11:08:01
Alerts & escalations
Routed to the right role · not a shared inbox
CAPA-441 SLA breach in 6h
Effectiveness check overdue
QA Lead
PM-318 coolant pump overdue
Line 3 · risk to yield
Maintenance
Training lapsed · 3 operators on SOP-2104
Blocks Line 3 reassign
Supervisor B
Lot LV-902 within 30 days of expiry
180 kg · prioritize on schedule
Planner
Push to mobile · escalates
Insight · Plant 1·Group Ops
MULTI-SITE · 11:09:48
Multi-site & multi-tenant
Shared masters · per-site overrides
Plant 1 · Reno NVOEE 84DEV 3OTIF 96%
Plant 2 · Atlanta GAOEE 79DEV 5OTIF 92%
Plant 3 · Dublin IEOEE 88DEV 1OTIF 98%
Co-man · São Paulo BROEE 71DEV 7OTIF 88%
Tenants
3 brands
Masters
Shared
Per-site
Overrides
Same engine · per-site context

Kiosk, desktop & mobile

Operators on kiosks, supervisors on tablets, managers on desktop — same data, role-appropriate views, with mobile alerts that follow the right person home.

Same codebase, your industry

The platform reshapes for your sector.

Kiosk tiles, sidebar, terminology, regulators and report names all change to match your industry. You never see someone else's workflow.

Medical Devices

Class I/II/III device manufacturers — eDHR, UDI, design controls.

Pharmaceutical

Drug manufacturers, compounders, OTC — full cGMP batch records.

Dietary Supplements

Vitamins, sports nutrition, nutraceuticals — 21 CFR 111 ready.

Food Processing

FSMA 204, HACCP, GFSI — preventive controls and traceability lots.

Bakery & Confectionery

Allergen control, label accuracy, sanitation cycles — without paper.

Produce Packing

FSMA Produce Rule + 204 — field to case in one clean record.

Sausage & Meat Products

USDA FSIS HACCP, lethality logs, label approval — production-grade.

Cosmetics & Personal Care

MoCRA registration, GMP, adverse event records — by construction.

Consumer Products

CPSC compliance, Prop 65, retailer chargebacks — controlled production.

Ingredients & Dry Mixes

B2B blends, custom formulas, customer COAs — release to spec, every time.

Plastics & Resins

Compounders & molders — recipe control, regrind tracking, customer specs.

Agricultural Chemicals

EPA registration, FIFRA labeling, batch identity for crop protection.

Radiopharmaceuticals

PET, SPECT, alpha & beta therapy — decay-corrected batch records & conditional release.

Cannabis & Hemp Manufacturing

Edibles, vapes, tinctures — state-GMP, METRC traceability, COA-per-batch.

Pet Food & Pet Supplements

Kibble, treats, supplements — FSMA + AAFCO + nutrient guarantee.

Veterinary Pharmaceuticals

Animal drugs — 21 CFR 211 + FDA CVM, with cold-chain and Annex 11 e-sigs.

Specialty & Industrial Chemicals

Coatings, adhesives, reagents — REACH, TSCA, OSHA PSM, GHS / SDS per lot.

Blood & Tissue

Blood centers, tissue banks, birth tissue — 21 CFR 1271 / 606, AABB, AATB.
See it like an inspector

Auditor mode — without the audit.

Every action in V5 lands as a signed, time-stamped row. Pick a scope and a regulator and we'll render a stylised preview of what an inspector would actually see.

Auditor mode preview

Pick a scope and a regulator. See a stylised audit trail the way an inspector would. Marketing illustration — generic names, real V5 structure.

Want V5 mapped to your floor? · 30s AI brief

What would V5 look like for your operation?

Modules, rollout, compliance fit, pricing band — grounded in V5's documented features.

Add SOPs, RFPs, or batch records on the next step.

See V5 Ultimate on your shop floor.

Free trial, no credit card, onboard in days, not months.