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.
Shop-floor execution
A locked-down, touch-first kiosk for operators — multilingual, offline-tolerant, gloves-friendly and signed at every step.
Add Citric Acid — Anhydrous
Lot CA-118-BPick from A-12-03
Stage 7- Pallet LP-887-02 · 4 × 25 kg sacksscanning
- Pallet LP-887-03 · 4 × 25 kg sacksqueued
- Pallet LP-887-04 · 2 × 25 kg sacksqueued
Tablet hardness
USP <1217>Quarantine lot CA-118-B
LP-887-02- A-12-03 → QA-HOLD-04
- System lock placed on lot
- NCR-4471 auto-opened
Scale SC-204 — out of calibration
PM-2117Last 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
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.
Guided dispense weighing
NowLive scale capture, tolerance bands, addition-order enforcement and two-person sign-off where regulated.
Directed picking & put-away
NowScan-to-confirm pick paths, license-plate pallets, mixed-pallet support.
In-process checks
NowWeight, hardness, dissolution, temperature, dimensional — captured at the step with pass/fail logic.
Move / withdraw / scrap / quarantine
NowEvery inventory transaction is a kiosk tile — no spreadsheets, no paper movement slips.
Maintenance & PMs
NowCalibration lockouts, PM scheduling, out-of-cal tools refuse to record measurements.
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.
OOS hardness on tablet press TP-04
SeverityClosed-loop investigation
SLA 30dLine 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
Lot CA-118-B · 4 200 units
QA-HOLD-04Complaints by lot · last 90 days
Threshold ≥ 4- CMP-2104Hardness — chipped tabletslot CA-118-B
- CMP-2107Bottle count short by 2lot CA-118-B
- CMP-2111Label print misalignedlot CA-118-C
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.
CAPA workflow
NowInvestigation, root cause, action plan, effectiveness check — full closed-loop with e-signatures.
Audits & inspections
NowInternal, supplier and regulator-prep audits with auto-routed findings and scorecards.
Holds & dispositions
NowLot/batch quarantine with disposition workflow (release, rework, scrap) and full justification trail.
Customer complaints
NowTied to the exact lot/serial; trends feed CAPA triggers automatically.
QC test management
NowSampling plans, test methods, CoA generation, OOS workflow.
Document & training control
One unified register for internal SOPs and supplier records. Operators are hard-blocked from work they're not currently certified for.
Tablet press cleaning — rev 7
supersedes rev 6Role × SOP coverage
4 ops · 4 SOPsOperator cannot start this step
Op: L. ParkStep requires SOP-122 rev 4. Operator is signed off on rev 3 — superseded 8 days ago.
- Read SOP-122 rev 4 (delta highlighted)
- Sign training acknowledgement
- Kiosk unlock — supervisor witness
Inbound CoAs & certifications
2 suppliers- expires 312dCoA · Citric Acid lot CA-118-BAcme Excipients
- expires 217dGMP audit certAcme Excipients
- expires 27dISO 9001 certVector Polymers
- expired 4d agoMaterial spec MS-104Vector Polymers
Impact assessment cascade
from CAPA-9912- DocumentsSOP-114, WI-204 — re-issue
- Training24 operators · re-qualification
- ValidationOQ §3.2 needs partial re-run
- EquipmentTP-04 PM cadence: 1.2M → 800k
Document register
Hybrid numbering, version control, retention schedules, periodic-review reminders — one unified register for internal SOPs and supplier records.
Two-person e-sig approval
Now21 CFR Part 11 compliant approval chains with reason-for-change capture.
Role-based training matrix
NowPer-role required reading, sign-off and re-qualification cadence.
Training-gated kiosk steps
NowOperator can't start a step if their training is expired or on a superseded SOP version.
Supplier document control
NowInbound CoAs, specs and certifications — expiries trigger requalification automatically.
Change control
NowLinked impact assessment across documents, training, validation and equipment.
Materials, formulas & genealogy
From inbound receipt and identity testing through finished-goods release, with full forward/backward traceability.
- FT-NIR fingerprintPass
- Loss on drying ≤ 5.0%Pass
- Protein (Kjeldahl) ≥ 78%Pass
- Heavy metals panelRunning
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.
Receiving & identity testing
NowInbound lots blocked from production until identity passes and QA releases.
Master formula / MBR library
NowApproved masters are immutable; every work order snapshots from a frozen revision.
Forward & backward genealogy
NowAPI → bulk → bottle in seconds. Recall scope returned in a single query.
Serialization & aggregation
NowGTIN + serial + lot + expiry. Parent-to-child aggregation for DSCSA, FMD and UDI.
Label-claim reconciliation
NowPer-serving values on the label computed from the batch — marketing and formula stay in lockstep.
Compliance & records
21 CFR Part 11 e-signatures on every critical action. ALCOA+ data integrity. Reports follow your industry's terminology.
- 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
Data integrity controls
Time sync, system-clock protection, user-action attribution and no-orphan-record enforcement — ALCOA+ by construction, not by convention.
Industry-shaped batch records
NowBMR for pharma, DHR for devices, BPR for supplements, batch records for food — same engine, right name.
21 CFR Part 11 e-signatures
NowAuthenticated, attributable, with meaning-of-signature on every critical action.
Immutable audit trail
NowEvery change attributable, contemporaneous and original — full reason-for-change capture.
Regulator-ready reporting
NowDSCSA, FSMA 204, GUDID/EUDAMED, USDA FSIS, EU FIR — pre-shaped exports per sector.
Validation pack (IQ/OQ/PQ)
NowIQ/OQ/PQ templates, validation summary and audit-trail review evidence shipped with the platform.
Integrations & APIs
V5 sits beneath your existing ERP and pushes verified production data back. Finance and purchasing stay where they are.
- GET /api/v1/lots
- GET /api/v1/work-orders/:id
- POST /api/v1/deviations
- POST /api/v1/lots/release
- • lot.released
- • deviation.opened
- • capa.closed
- • supplier.qualified
Carrier & 3PL bridges
Shipment manifests, BoL and ASN out to your customers and 3PL of choice — same engine, no separate logistics module to staff.
ERP & accounting bridges
NowSAP, NetSuite, Sage, QuickBooks, Microsoft Dynamics — verified production data pushed back in real time.
REST API & webhooks
NowModern REST API and event webhooks for any downstream system you care about.
PLC / SCADA / IoT
NowProbe temps, scale captures, oven dwell, cooling tunnels — streamed straight to the batch record.
Label & print
NowZebra, SATO, Domino, Videojet — print at the workstation, scan at the line.
SSO & identity
NowSAML, OIDC, Azure AD, Okta. SCIM provisioning. MFA enforced for signers.
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.
Two deployments, one substrate
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.
Insight, AI & operations
Live dashboards, predictive alerts and an AI assistant that knows V5, your industry and your data.
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.
Live dashboards
NowOEE, yield, scrap, deviation rate, on-time-in-full — out of the box, drillable per line and shift.
KPIs & scorecards
NowSupplier scorecards, operator performance and line-level quality trends — shipped, not configured.
Ask V5 assistant
NowNatural-language queries across batches, deviations, suppliers, training and SOPs — with citations.
Alerts & escalations
NowPM overdue, training lapsed, lot near expiry, CAPA SLA breach — routed to the right role, not a shared inbox.
Multi-site & multi-tenant
NowRun multiple plants, brands or legal entities with shared masters and per-site overrides.
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

Pharmaceutical

Dietary Supplements

Food Processing

Bakery & Confectionery

Produce Packing

Sausage & Meat Products

Cosmetics & Personal Care

Consumer Products

Ingredients & Dry Mixes

Plastics & Resins

Agricultural Chemicals

Radiopharmaceuticals

Cannabis & Hemp Manufacturing

Pet Food & Pet Supplements

Veterinary Pharmaceuticals

Specialty & Industrial Chemicals

Blood & Tissue
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.
What would V5 look like for your operation?
Modules, rollout, compliance fit, pricing band — grounded in V5's documented features.
See V5 Ultimate on your shop floor.
Free trial, no credit card, onboard in days, not months.
