Total QMS Control with V5 Enterprise

Already running V5 MES or WMS? You’ve laid the foundation. Now it’s time to complete the system and close the loop with the
QMS module — exclusively available in the V5 Enterprise tier.

Designed for regulated industries such as food, dietary supplements, cosmetics, medical devices, and pharmaceuticals, V5 QMS offers more than traditional document control or disconnected audit logs. It delivers active enforcement of quality procedures at the moment they matter — when your operators are weighing, scanning, sampling, packing, labeling, and moving product.

Unlike static quality systems that rely on human memory or external uploads, V5 QMS integrates directly into the V5 platform — leveraging triggers from MES, WMS, and traceability activity to enforce procedures, escalate issues, and capture actions as they occur. This means that deviations, CAPAs, document sign-offs, and training enforcement are automatically tied to shop floor execution — not filed away for later reconciliation.

“With QMS, our allergen checklists are now mandatory before any line starts. That’s a huge win. It took quality from something we checked at the end to something we enforce up front.”

– QA Director, Global Snack Manufacturer

How V5 QMS Enforces Quality in Real Time

V5 QMS stands apart by embedding quality checkpoints inside the operational workflow. From scanning materials to weighing ingredients, performing line checks, or releasing batches — V5 can enforce your SOPs through digital trigger points tied to defined escalation protocols.

• Line startup events can require checklist completion or supervisor sign-off
• Material receipt can prompt allergen, cleaning, or supplier verification steps
• Failed tolerances trigger automatic NCR creation with CAPA workflow routing
• Operator logins validate training certification and prevent unauthorized access
• Test results and lab sampling are logged and scheduled inside LIMS workflows

The result? A single platform where your QMS doesn’t just document — it defends your quality process from deviation, risk, and regulatory gaps.

“We used to scramble during inspections. Now everything is already where it should be. Document control, training logs, CAPAs — it’s all live and accessible instantly.”

– Operations Manager, Nutraceuticals Co-Packer

QMS That Meets FDA, ISO, and GMP Requirements

If your company must comply with 21 CFR Part 11, 111, 211, 820, EU Annex 11, or ISO 13485 — you know documentation isn’t enough. Regulators want to know how your systems prevent quality issues, not just how you report on them.

V5 QMS allows you to prove procedural enforcement, system access control, electronic signatures, and batch-level traceability — all built into the digital thread of your manufacturing execution. Every action is traceable, timestamped, role-restricted, and audit-ready by default.

• Electronic records with full audit trails and user attribution
• CAPA escalation routing by severity and time window
• Checklist compliance tied to shift, product, or production stage
• Document version control with automated expiration handling
• SOP access and approval workflows by department or product
• Training modules with testing, scoring, and automatic certification

“In pharma, data integrity is everything. V5 gives us traceable sign-offs, lab logs, asset maintenance, and SOP compliance in one place — tied to every batch.”

– VP Quality, Contract Pharmaceutical Manufacturer

From Line Checks to Full Quality Control

Only the Line Check feature — including real-time allergen prompts, hazard warnings, and Q&A-style production validation — is available in Express and Professional tiers. All other QMS modules, including Document Control, Training, CAPAs, LIMS, and Approvals, are exclusive to V5 Enterprise. If you’re using Line Checks today, upgrading to Enterprise unlocks the rest of the quality enforcement stack.

Included QMS Modules in V5 Enterprise

When you move to V5 Enterprise, you unlock the full QMS stack — not as a bolt-on, but as a fully integrated part of your digital manufacturing platform:

• Policies & SOPs – Define and assign procedures with versioning and audit logs
• Training – Create training modules, schedule certifications, and test comprehension with AI-assisted Q&A tools
• Document Control – Secure and manage document types, approval flows, supplier attachments, and expiration alerts
• Checklists – Configure reusable checklists tied to users, roles, products, and schedules
• Line Checks – (Available in all tiers) Prompt QA confirmations tied to WMS and MES activities in real time
• Quality Issues – Centralize and manage deviations, complaints, NCRs, CAPAs, and audit trails
• Approvals – Route approvals based on templates, deadlines, and escalation rules
• LIMS – Define and track test methods, sample scheduling, lab supplies, and equipment readiness
• Assets – Assign maintenance tasks, calibrations, and usage logs with integration into product and process execution

The integration between QMS, MES, and WMS ensures that all enforcement, alerts, escalations, and documentation are part of the same platform — no sync errors, no external silos, and no workarounds.

See It in Action — Book a Demo

If you’re running V5 Express or Professional today, upgrading to Enterprise unlocks the full QMS feature set. You’ll go from documentation to enforcement — from passive records to active quality assurance.

Schedule a personalized demo to explore how V5 Enterprise can help your facility enforce, document, and prove quality — from the first raw material scan to the final release signature.

Already using V5? Let’s talk about unlocking QMS and making compliance a living, breathing part of your manufacturing execution system.