V5 Traceability - Smart FAQs
for Regulated Manufacturing

V5 Traceability is a real‑time execution and traceability platform built for regulated, batch‑based manufacturing. It helps you run the floor with live enforcement of steps, QA checks, inventory moves, labels, and audit‑ready records.

If your process is split across paper, spreadsheets, and ERP transactions after the fact, V5 is the layer that makes execution clean and verifiable while it’s happening.

V5 can cover MES (execution), quality workflows (QMS‑style processes), and inventory movement (WMS‑style processes) in one unified system. What you get depends on the tier you select (Express / Professional / Enterprise) in your Order Form / Signed Proposal.

• Goal: one source of truth for floor execution + quality + inventory, without gaps that create deviations and audit pain.
• Reality: we can phase it in (start with core execution, then expand once you’re stable).

ERP is great for planning, purchasing, finance, and reporting. It’s not built to enforce shop‑floor steps in real time. V5 is the “system of execution” — it guides what must happen during production and captures an audit trail automatically.

In most deployments, ERP remains the system of record, and V5 integrates to keep execution and inventory aligned (when integration is purchased and scoped).

• Operators: guided steps, scanning, weighing, labeling, confirmations.
• QA: in‑process checks, approvals/signoffs, exceptions (as configured).
• Supervisors: batch status, exceptions, throughput visibility.
• Warehouse: receipt, putaway, picking, staging, shipping traceability.
• Management: KPIs without chasing paper.

Both are available. Deployment is defined on your Order Form / Signed Proposal. On‑Premise is the default deployment unless Hosted is explicitly elected.

• On‑Premise: you control infrastructure; you own backups/DR/security at the infrastructure layer.
• Hosted: we operate the environment and provide SLA‑backed uptime and recovery commitments.

Infrastructure baseline and supported peripherals are documented here: V5 System Requirements.

Usually no. Most customers run V5 on standard shop‑floor HMIs (industrial PCs, touchscreens, tablets) plus normal office machines for QA/admin. We don’t force a bundled hardware model.

Minimum server/endpoint requirements (plus supported scanners, scales, and ZPL label printers): V5 System Requirements.

No — not by default. A “Device” is an HMI (PC/tablet) used by a human to access V5. Passive peripherals (scanners, scales, printers) do not count as licensed Devices unless expressly listed as licensed HMIs on your Order Form / Signed Proposal.

Peripheral support and on‑prem environment expectations: V5 System Requirements.

Yes. Initial onboarding/implementation is a paid, one‑time professional service scoped after consultation and shown as upfront one‑time fees on your Order Form / Signed Proposal.

The point is predictability: regulated deployments need real project structure and clean scope, not vague “included onboarding” that collapses under QA and audit scrutiny.

Onboarding stages and prerequisites: Onboarding Process.

Onboarding scope is tailored to your environment, but common line items include:

• Project management: kickoff, timeline, weekly status cadence, issue tracking.
• ERP Gap Analysis (if purchased): confirms ERP readiness, required objects, mappings, and integration approach.
• Custom API integration (if purchased): customer‑specific mappings/connectors and test support.
• Configuration: roles/permissions, workflows, templates, compliance‑relevant settings.
• Training sessions: operators, QA, supervisors, admins (as scoped).
• UAT / IQ/OQ support (if included in scope): facilitation and validation templates/assistance when purchased (see Compliance & Validation section below).

Your Order Form / Signed Proposal should spell out exactly what you’re buying so expectations are clean on both sides.

Your initial payment typically includes:

• One‑time onboarding fees (ERP Gap Analysis, integration, project management, etc. — if purchased), and
• Subscription payment due at signing (either the first month if monthly billing, or the full year if annual billing).

We schedule onboarding and provision access once the Order Form / Signed Proposal is executed and the required initial payment is received.

Not automatically. ERP integration is provided only if it’s expressly purchased and scoped because it depends on your ERP objects, your data quality, your workflow design, and your validation expectations.

We can also go live without ERP integration and add it later — that’s often the cleanest risk‑reduction approach.

ERP Gap Analysis is a structured review of your ERP’s data model and workflows to confirm what’s needed for reliable integration. It typically produces a mapping plan (what fields map to what), identifies missing objects/fields, and outlines test strategy.

It’s commonly ordered in advance because it prevents “integration rework” and timeline blowups later.

Typical go‑live is 4–8 weeks once scope is set and we have timely access to your people, environments, and master data. Integration projects (especially with customized ERPs) can extend timelines — the fastest projects are the ones with clean inputs.

The biggest lever for speed isn’t “working harder.” It’s fast decisions, clean data, and access to the right systems.

Yes. After initial setup, during an active subscription we provide reasonable remote assistance for additional onboarding questions, training refreshers, and operational guidance.

Major expansions (new sites, new integrations, significant workflow redesign, on‑site programs, or net‑new development) are scoped and priced separately so it stays predictable.

Either. Your Order Form / Signed Proposal specifies whether your subscription is User‑Based or Device‑Based.

• User‑Based: licenses are assigned to named individuals (not shareable).
• Device‑Based: licenses are assigned to specific HMIs (PCs/tablets) identified by hardware identifiers.

Yes — customers must maintain at least three (3) active user licenses or at least one (1) device license, depending on the licensing model selected.

• Add/upgrade mid‑term: yes — typically prorated for the remaining term.
• Downgrades: generally take effect at the next renewal (per your MSA/Order Form terms).

V5 includes regulated‑environment controls (audit trails, access controls, electronic signatures, and traceability features). The right way to think about it: V5 supports compliance, but your quality system + your validation in your environment is what makes it audit‑defensible.

Yes. During an active subscription, we provide access to our independent Assessment Documentation for V5 (Version 5.9) at no additional charge upon request, subject to confidentiality terms.

This is designed to shorten the “prove it” cycle with QA and external auditors without pretending that validation can be outsourced.

Yes — when it’s included in your purchased onboarding scope.

• Enterprise customers: if your Order Form / Signed Proposal includes the Enterprise onboarding/validation package as part of paid Onboarding / Implementation Services, we provide UAT planning structure, facilitation support, and issue triage/retest coordination as part of that onboarding scope.
• Other tiers: you can still purchase UAT facilitation as part of onboarding if you want structured support.

In all cases, Customer QA owns final acceptance and sign‑off within the Customer quality system.

Yes — we support IQ/OQ in a way that’s realistic for regulated environments.

• Enterprise customers: if your Order Form / Signed Proposal includes the Enterprise onboarding/validation package within paid Onboarding / Implementation Services, we provide an IQ/OQ template package and reasonable remote assistance (answering questions, explaining software behavior, supporting execution).
• Other tiers: validation templates/assistance can be included if purchased in onboarding scope; otherwise we still provide reasonable guidance on software behavior and configuration as needed.

Bottom line: we support you, but Customer remains responsible for execution, review, approval, and maintenance of validation deliverables in the Customer environment.

Updates follow change‑control principles: visibility into what changed (release notes), time to evaluate validation impact (especially for Hosted), and controlled deployment expectations. For Hosted environments, major updates are typically communicated in advance; emergency security patches may be deployed faster when required.

You own your Customer Data. We use it only to provide and support the service. For Hosted Services, offboarding/export is handled per the post‑termination retrieval window in your MSA.

If you plan to offboard, tell us early so exports happen cleanly and on your timeline — not during a fire drill.

You’ll receive support channels during onboarding and ongoing access during the subscription. Response targets depend on severity:

• Severity 1 (Critical): 90 minutes, 24/7/365
• Severity 2 (High): response within 4 business hours
• Severity 3 (Medium): response within 8 business hours
• Severity 4 (Low): response within 2 business days

The goal isn’t “fast emails.” The goal is keeping production running and keeping you audit‑safe.

In both models, we support the Software: troubleshooting, operational questions, and guidance.

• Hosted: we support the service operation plus the Software (and SLA‑backed uptime/recovery).
• On‑Premise: you own infrastructure uptime/backups; we support Software functionality and usage.

Yes — V5 may collect Usage Data (telemetry) to keep the service reliable and secure, enforce licensing, and improve the product.

• Essential telemetry (security/service delivery/license enforcement) stays on.
• Non‑essential analytics can be disabled by written notice per the MSA process.
• Retention: raw usage data is retained for up to 13 months (unless longer is required for security/audit/legal hold).

If your compliance team needs privacy terms or a DPA, we can provide it as applicable.