V5 Traceability - Smart FAQs
for Regulated Manufacturing

Many MES platforms look good in demos but struggle in the reality of day-to-day manufacturing—especially in regulated industries. V5 is different. It was built from the ground up for complex, high-compliance environments like pharma, food, and supplements. With native support for traceability, electronic records, QA enforcement, and lot-level batch control, V5 doesn’t just track data—it enforces the process.

While others focus on paperwork automation, V5 drives the actual production.

It’s not about checking a box—it’s about making the batch right, every time. That’s why V5 is trusted by manufacturers who can’t afford to guess.

Most V5 users see ROI in under 6 months. Expect faster batch cycles, fewer errors, eliminated paperwork, reduced rework and scrap, and drastically shorter QA review times. It’s not just a compliance tool — it’s a production accelerator.

Paper records are slow, error-prone, and non-compliant by modern standards. V5 delivers real-time, locked traceability with full audit trails, digital signatures, and built-in deviation and CAPA workflows. You’re audit-ready at all times — not just during inspections.

V5 is used by operators (guided steps), QA teams (in-process approvals), supervisors (live dashboards), warehouse staff (material scanning), and managers (KPI tracking). Everyone on the floor benefits — and nothing falls through the cracks.

Yes. Operators get simple, multilingual, touchscreen workflows with clear instructions and role-based access. It removes paperwork, reduces interruptions, and keeps production flowing without confusion or micromanagement.

V5 is built from the ground up for regulated manufacturing. It includes native support for 21 CFR Part 11 and EU Annex 11, complete with audit trails, version control, and electronic signatures. Whether you’re facing FDA, EMA, or ISO inspections, V5 ensures your records are compliant, secured, and accessible—with sandbox environments and validation templates ready for your QA team.

V5 integrates with ERP, LIMS, and connected shop floor devices through a secure API framework. Standard ERP integration is included in your subscription for one ERP system with commonly used objects (POs, SOs, BOMs, etc.). If your ERP is customized or nonstandard, we’ll work with you—but custom mappings or extended integrations may require additional time or resources.

V5 runs on Windows-based touchscreens, industrial PCs, and tablets. If you have existing hardware, we likely support it. No device lock-ins or bundled hardware requirements — use what works best for your environment.

Smaller teams using V5’s standard modules can go live in just a few days. Larger rollouts typically take 4–8 weeks. We handle configuration, training, batch setup, and integration — and we don’t leave until your first batch runs clean.

If you request continuous custom development or major process changes mid-onboarding, the timeline may extend. That’s no problem — but to keep things moving, we recommend starting with the standard toolkit included in your subscription, then layering in enhancements post go-live. Full onboarding support is included for the first 90 days, with extended services available if needed.

V5 is designed for rapid implementation using preconfigured workflows and sample data aligned to your selected tier. We guide customers through a typical setup in 4 to 8 weeks. While our MSA encourages completion within 90 days, this isn’t a hard limit—just a best practice. If you’re paying the subscription, you’re free to phase in the system at your own speed. Extended implementation support is available if needed.

V5 is ideal for pharmaceuticals, supplements, food & beverage, cosmetics, agrochemicals, and CDMOs. If you make regulated products in batches and care about traceability, we’re built for you.

We moved from perpetual and device-based licensing to user-based models. Why? Teams are more dynamic, users change roles, and IT needs better control. Per-user licensing keeps things scalable, secure, and simple.

We honor all legacy agreements. But if you want the flexibility of user-based licensing, we’ll help you transition at your own pace — with clear guidance, no pressure, and no loss of functionality.

If your feature benefits the broader community, we’ll often build it, release it to your branch, and include it in the next release — at no extra cost. For highly specific requests, we’ll quote cleanly as a custom module, with documentation and validation control.

We’ve spent two decades in regulated manufacturing and built V5 with input from our advisory panel — made up of former QA directors, plant managers, and compliance leads from pharma, food, and contract manufacturing. We know the space because we’ve lived it — and continue to learn from the best.