Direct answers — not a marketing maze.

V5 Ultimate is a regime-aware shop-floor execution platform for regulated manufacturers. It bundles MES, WMS and QMS into one record so every batch, lot or serialized unit ships with a complete, signed production record assembled in real time as the operator works.

Both, in one record. V5 ships MES (execution, routings, equipment), WMS (receive, dispense, pick-pack-ship) and QMS (deviations, CAPA, change control, audits) on a single immutable batch record so quality events and execution events share one timeline.

Yes. V5 enforces Part 11 in code: identity-verified e-signatures on every gated step, immutable audit trail with hash-chained record versions, role-based access controls, and PDF renderings of every batch record signed under the same identity bound to the action.

Yes. V5 ships with the Annex 11 controls EU inspectors look for: validated computerised system, risk-based change control, periodic review, incident management, and a full audit trail. Validation artefacts (URS, FS, IQ/OQ/PQ templates) are included for Validated Enterprise tier customers.

FSMA Section 204 is the FDA Food Traceability Rule, fully enforced January 2026. It requires Key Data Elements at every Critical Tracking Event for foods on the Food Traceability List. V5 captures CTEs at receive, transform, ship and reconciles lot codes back to the sortable spreadsheet the FDA can request within 24 hours.

ISO 13485:2016 is the international QMS standard for medical devices. It requires controlled documents, training records, design controls, CAPA, supplier controls and risk management. V5 enforces these in execution — operators are blocked from steps they aren't trained for, change control routes through approval, and records are immutable.

An electronic Device History Record is the complete, signed record of a finished medical device — materials, operators, equipment, in-process checks, UDI and e-signatures — required under 21 CFR 820.184 for every unit a device manufacturer ships. V5 builds it automatically as operators work.

A BMR is the live, signed reproduction of an approved Master Manufacturing Record for one specific batch, required under 21 CFR 211.188. It captures every weighment, in-process check, deviation and signature in sequence so QA can release the batch from a single immutable document.

A Unique Device Identifier (21 CFR 830) is a GS1 DataMatrix that pairs a Device Identifier (GTIN) with a Production Identifier (lot/serial, expiry). V5 generates and prints the UDI at the assembly workstation, validates the encoding, and reconciles it to the FDA GUDID submission.

Pharma, medical devices, dietary supplements, food processing, sausage & meat, bakery & confectionery, ingredients & dry mixes, produce packing, cosmetics, cannabis, pet food, veterinary pharma, plastics & resins, agricultural chemicals, radiopharmaceuticals, chemicals, blood & tissue, and consumer products. Each ships with its regulator-specific terminology, records and gates.

Yes. V5 ships AAFCO guaranteed-analysis controls, label-claim verification at release, FDA CVM nutrient profile checks, and FSMA preventive controls for animal food (21 CFR 507). The batch record carries the analytical CoA against the claimed analysis automatically.

Yes. V5 syncs harvest, package, transfer and lab-test events with METRC via its state APIs in every state that uses METRC. The same connector pattern extends to BioTrack and Leaf Data Systems for non-METRC states.

V5 enforces allergen sequencing on shared equipment, blocks campaigns that violate the allergen matrix, requires verified cleaning checks between runs (with TOC/ATP results captured to the record), and prints allergen-correct labels gated on the verified cleaning state.

Both. V5 runs on Lovable Cloud for fast time-to-value, or as V5 Ultimate On-Premises — a containerised, air-gap capable deployment where the customer owns the database and encryption keys. The application code is identical; only the hosting and key custody differ.

Yes. For regulated (GxP) sites the pre-validated path is a Linux VM (Ubuntu 22.04 or RHEL 9) on the customer's Hyper-V, VMware, Nutanix or Proxmox host — covered by the shipped IQ/OQ pack at no extra cost. For non-regulated sites you can also run V5 directly on Windows Server via Docker Desktop + WSL2 under the standard support term.

Only relevant at regulated (GxP) sites. The shipped IQ/OQ pack covers the Linux-VM-on-Hyper-V (or VMware / Nutanix / Proxmox) pattern at no extra cost. Validating a Windows-native install (Docker Desktop + WSL2 directly on Windows Server) for a regulated site is a chargeable engagement. Non-regulated plants don't need an IQ/OQ pack — pick whichever option fits IT.

No. The V5 application ships as Linux OCI container images — there is no Windows-native binary of the app tier. On Windows Server it runs either inside a Linux guest VM (recommended, fully validated) or via Docker Desktop with WSL2 (Linux kernel under the hood). Postgres, by contrast, runs natively on Windows Server and is fully supported as the database tier.

A single-site Express deployment is typically running in 2–4 weeks: one industry preset, one or two lines, one ERP feed. Pro deployments with multi-line and validated change control are 8–12 weeks. Validated Enterprise (multi-site, full IQ/OQ/PQ) runs 12–24 weeks depending on validation scope.

Standard industrial tablets or panel PCs with a browser, a barcode/DataMatrix scanner, a label printer (Zebra ZPL or equivalent), and serial/Ethernet feeds from scales and equipment. V5 has no proprietary hardware lock-in.

V5 is validatable, and Validated Enterprise customers receive a full validation pack: URS, FS, configuration spec, IQ/OQ/PQ protocols, traceability matrix, validation summary report, and periodic-review templates aligned to GAMP 5.

Workstations run a local queue — operators can keep dispensing, weighing and signing for several hours of intermittent outage. When the network returns, the local queue replays in order; signatures and timestamps are preserved and the audit trail records the offline window.

Lovable Cloud customers can pick US, EU or APAC regions; data stays in-region. On-premises customers store data on their own infrastructure — V5 holds no copy. All data at rest is encrypted with AES-256; all traffic is TLS 1.3. Per-tenant row-level security isolates every customer.

You do. Your batch records, master data, audit trails and uploaded documents remain your property. V5 has a contractual obligation to return all tenant data on request in a structured, portable format (CSV/JSON + PDF renderings) and to destroy any residual copies after a defined retention window.

No. V5 extends your ERP — it owns shop-floor execution, quality and the production record; your ERP keeps owning financials, procurement and the general ledger. V5 ships connectors for SAP, Oracle, NetSuite, Dynamics 365, Sage and Acumatica, plus a generic CSV/REST/IDoc bridge.

Yes. V5 ships a SAP connector for material masters, BOMs, production orders and goods movements via BAPI/IDoc or SAP API Business Hub. Confirmations and consumption flow back automatically as the batch is executed.

Yes for both. V5 syncs items, BOMs, work orders and inventory movements via NetSuite SuiteTalk / REST and Dynamics 365 OData. Real-time webhooks keep ERP inventory and V5 lot positions reconciled.

Yes. V5 reads weight streams from Mettler Toledo, Sartorius, Ohaus and any scale exposing a serial/Ethernet stream. Process equipment with OPC-UA, MQTT or Modbus feeds straight to the batch record — temperature, RPM, dwell, torque are captured contemporaneously, not transcribed.

V5 has three tiers: Express (usage-based, no minimum), Pro (per-site monthly with included AI credits) and Validated Enterprise (annual, fixed, includes validation pack and 24/7 support). Pricing is published on the pricing page — no quote-for-everything model.

No. V5 is priced per site and per usage, not per named operator seat. Shop-floor workstations are unlimited within a site; you only pay for the site, AI usage and any optional add-ons.

Yes. Express tier is free to start with no credit card — you can stand up an industry preset, run a sandbox batch and see your record assemble in real time within minutes.

MasterControl is a document-centric QMS — it manages SOPs, change control and CAPA. V5 is execution-first: it runs the floor and records every action against the SOP in one immutable batch record. Customers typically replace MasterControl's manufacturing module with V5 and keep MasterControl for document management, or move documents to V5 too.

Tulip is a low-code app builder for operations — you build your own apps. V5 ships configured for your industry on day one with regulator-specific records, e-signatures and audit trail built in. Tulip is faster to prototype; V5 is faster to audit-ready production.

Veeva Vault owns the document and quality system layer in big pharma. V5 owns shop-floor execution and the live batch record. They overlap on QMS workflows but Veeva does not run the floor; V5 plugs into Veeva for document control and submits batch release events back to Vault.

Yes — that is the primary use case. V5 replaces paper BMRs and DHRs with an electronic record that assembles itself as operators work, eliminates transcription errors, enforces step gating, and produces a PDF identical to what auditors expect — signed under 21 CFR Part 11.