V5 Traceability - Smart FAQs
for Regulated Manufacturing

SG Systems Global supplies software for regulated manufacturing environments. V5 Traceability is the company’s execution and traceability platform for production, quality, warehouse, and batch-driven operations that need structured workflows, attributable evidence, and records that support release, investigation, and audit activity.

In practical terms, V5 is meant to help customers run work in a controlled sequence, capture evidence at the point of execution, and reduce the gap between what happened on the floor and what can actually be shown later.

Related pages: About SG Systems • Leadership & Governance

V5 is aimed at manufacturers that need more than after-the-fact reporting. The strongest fit is for operations that must guide execution, enforce procedural steps, capture exceptions when they occur, and retrieve evidence quickly when QA, customers, or regulators ask questions.

That includes food, beverage, supplements, cosmetics, medical device, pharmaceutical, biotech, and similar sectors where traceability, quality control, and disciplined execution have to hold up under review.

V5 is positioned as a unified execution layer that can cover MES-style execution, QMS-style quality workflows, and WMS-style inventory movement in one system. The exact depth depends on the tier selected and the scope actually purchased.

SG Systems’ current standard licensing model is seat-based. A Seat is measured by concurrent use, not total headcount. That means a customer may have more named people configured in the system than seats purchased, so long as the number of simultaneously active users does not exceed the licensed seat count at any time.

This is different from a named-user model. It is also different from a device-tied licensing model. The current commercial baseline is about how many users can be active at the same time.

A seat license allows one concurrently active user session at a time. If a customer buys 10 seats, up to 10 users can be active simultaneously. The customer may have more than 10 people trained or authorized in total, but only 10 can be using the software at the same time.

SG Systems may use session controls, authentication controls, and audit logs to enforce seat counts and prevent workarounds.

SG Systems’ current standard model for new business is seat licensing measured by concurrent use. Historical named-user and device-based structures are no longer the standard model for new sales or fresh quotes.

That said, some long-standing customers were already converted from older commercial structures into a subscription model and may still operate under grandfathered subscription terms. That can include older pricing, similar pricing with annual increases, or an older commercial treatment that SG Systems has agreed to continue honoring.

Those customers are still subscription customers. They are not operating under a live perpetual commercial model. The grandfathering relates to pricing and commercial treatment, not to an exemption from renewal and payment obligations.

While the account remains current on all undisputed payments, SG Systems may continue to honor that grandfathered treatment and may also continue to expand the subscription by adding additional licensing under that customer’s existing commercial framework, provided the change is documented in a current quote, invoice, renewal, Order Form, or other written commercial record.

If the customer does not make timely payment of an undisputed invoice, SG Systems may restrict, suspend, or disable access immediately, including through automated system controls. Late payment can also cause the customer to lose the benefit of its grandfathered pricing and commercial treatment. After that, any continued access, reinstatement, renewal, or future expansion may be re-quoted under SG Systems’ then-current pricing, terms, and seat-based licensing model.

Unless otherwise expressly stated in writing by SG Systems, the current minimum purchase threshold under the standard licensing model is three (3) seats.

Some existing grandfathered subscription arrangements may differ where that commercial treatment is still being honored, but new standard commercial business is based on seat quantities.

Website pricing tools and public commercial examples are directional aids. They are useful for budget framing and early internal discussion, but they are not the binding source of truth if a signed Order Form, renewal, quote, or MSA says something more specific.

The controlling commercial documents are the current MSA plus the applicable Order Form, Signed Proposal, renewal, invoice, and any incorporated addenda.

SG Systems offers both Hosted Services and On-Premise Installation. Under the current MSA, On-Premise is the default deployment architecture unless Hosted is clearly elected on the Order Form or Signed Proposal.

No. A Device in the contractual sense is a human-machine interface such as a PC or tablet used by a person to access the software. Passive peripherals such as scanners, scales, and printers do not count as licensed HMIs unless expressly identified that way in a written commercial document.

For On-Premise deployments, customer IT owns servers, infrastructure security, backups, disaster recovery, monitoring, supporting third-party software, and the practical network connectivity required for endpoints, SQL, printers, and approved remote support paths.

SG Systems supports the application layer. Customer IT owns the environment layer.

Yes. Onboarding is a paid, one-time professional service. It is not presented as free or automatic. Typical onboarding structure includes planning, setup, training, and go-live/validation support depending on what is actually purchased.

• Project kickoff and readiness alignment
• Configuration and workflow setup
• Training by role
• ERP Gap Analysis or integration work if purchased
• UAT and IQ/OQ assistance where included

No. ERP integration, ERP Gap Analysis, and Custom API Integration are provided only if expressly purchased and described in the applicable commercial documents. They are not automatically included just because a customer has an ERP.

ERP Gap Analysis is the structured review of the customer’s ERP objects, fields, mappings, workflow gaps, and realistic interface approach before custom integration work starts. It reduces false assumptions and helps stop integration projects from being scoped on wishful thinking.

V5 is presented as supporting regulated-use controls such as access control, audit trail, electronic signatures, data integrity, controlled workflows, and attributable evidence structures relevant to Part 11, Annex 11, and broader GMP-aligned expectations.

The hard line remains the same: software can support compliance, but customer intended use, SOPs, training, configuration, access governance, and validation inside the customer quality system still determine whether the deployment is defensible.

SG Systems states that it provides access, during an active subscription and subject to confidentiality obligations, to independent assessment documentation for V5 Software Version 5.9 to support supplier qualification, CSV review, and audit discussions.

That documentation is evidence for supplier assessment. It is not an FDA approval, not a blanket certification, and not a replacement for site validation.

See: Independent 21 CFR Part 11 Assessment

Yes. SG Systems can provide UAT planning support, issue triage/retest coordination, IQ/OQ templates, and reasonable remote assistance where those services are included in the onboarding or implementation scope.

Final validation execution, review, approval, and release decisions remain customer-owned.

The public security position is framed as a risk-based information security program intended to protect confidentiality, integrity, and availability for customer data and services, especially in regulated manufacturing environments.

Hosted and On-Premise responsibilities remain different. Hosted commitments apply to the hosted boundary. On-Premise customers remain responsible for customer-controlled infrastructure, backups, patching, and environment security.

See: Security & Trust

• Severity 1 / Critical: response within 90 minutes (24/7/365), resolution within 4 hours
• Severity 2 / High: response within 4 business hours, resolution within 24 business hours
• Severity 3 / Medium: response within 8 business hours, resolution within 5 business days
• Severity 4 / Low: response within 2 business days, resolution within 10 business days

Business hours are Monday through Friday, 8:00 AM to 5:00 PM Central Time, excluding U.S. federal holidays, unless otherwise agreed in writing.

Each Order Form, renewal, or recurring commercial arrangement establishes a 365-day subscription term. Terms automatically renew unless the customer gives written cancellation notice at least 30 days before the next term starts.

For converted legacy customers, grandfathered subscription terms may continue to be honored while the account remains current on all undisputed invoices. If the account does not remain current, grandfathered treatment can be lost.

If an undisputed amount is not paid by its due date, SG Systems may restrict, suspend, or disable access immediately, including by automated system controls. If the account remains unpaid, support may be paused, Hosted Services may be suspended, and the applicable services may ultimately be terminated for cause under the MSA.

For customers operating under grandfathered subscription terms, late payment can also cause loss of grandfathered pricing and expansion treatment.

Onboarding fees are billed upfront and are generally non-refundable once paid. Subscription and other service fees are also non-refundable unless the MSA or applicable commercial documents expressly say otherwise.

Cancellation, non-use, delay, or project abandonment does not create an automatic refund right.

Customer retains ownership of Customer Data. During the subscription, SG Systems will make commercially reasonable efforts to support export using standard methods. For Hosted Services, Customer Data remains retrievable for 90 days post-termination upon request, provided all undisputed amounts have been paid.

Custom exports may require separate written agreement. Practical advice: do not leave extraction planning until the last week.

The controlling documents are the current MSA, the applicable Order Form, Signed Proposal, renewal, invoice, and any incorporated addenda such as the Supplier Quality Addendum. This FAQ is an informational summary only and does not override signed commercial or legal documents.

• Order Form / Signed Proposal / Renewal / Invoice: scope, pricing, quantities, deployment election, and commercial selections
• Supplier Quality Addendum, if incorporated: regulated operational constructs and support boundaries
• MSA: broader legal, licensing, commercial, security, SLA, and customer-data framework