A manufacturing execution system that goes live before the consultants finish discovery.
Most MES projects are eighteen months and seven figures before anyone signs a batch. V5 Ultimate is the manufacturing execution system pre-configured for regulated production — work orders, electronic batch records, OEE, deviations, calibration — running on the same platform as your QMS and integrated with your ERP from day one.
If you've watched an MES quote come in at seven figures, you've already had the problem.
The MES quote is bigger than the line it's running
Your ERP's MES module won't pass a Part 11 inspection
Paper travelers next to a $40M ERP system
OEE is a monthly PowerPoint, not a dashboard
Deviation catches happen at end-of-batch, not at the failing step
Equipment status is a clipboard on a binder on a shelf
A real MES — dispatch, execution, signal, control.
Work order dispatch
ERP order → schedule → kiosk → sequenced steps. Material status, equipment status, training status — all enforced.
Electronic batch / device records
Signed eBR and eDHR on the same engine, under Part 11 and Annex 11.
Real-time OEE
Availability, performance, quality — by machine, line, shift. Live to operators, not in a Monday report.
Deviation at the failing step
An out-of-spec weighing pages QA right then. Next step blocks until disposition.
Equipment + calibration
Locked-out equipment can't be selected. Calibration due-dates are a hard gate.
ERP integration
NetSuite, SAP, Dynamics, QuickBooks Enterprise, Sage X3 — signed REST + webhooks, idempotency-safe.
A modern MES rewires the floor, not just the screens.
- First signed batch in 30 days — every plant, every time
- Batch-record review collapses 60–80%
- OEE becomes a real signal, not a retrospective
- Deviations get caught and dispositioned at the failing step
- Inventory gap between ERP and floor closes in the first month
MES that holds up against Part 11, Annex 11, and GAMP 5.
21 CFR Part 11
§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.
EU GMP Annex 11
Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — covered out of the box.
GAMP 5 Second Edition
Category 4 configured product with documented critical thinking. CSA-aligned test evidence delivered with onboarding — not a six-month after-the-fact project.
Manufacturing execution system, answered.
What is a manufacturing execution system (MES)?
An MES is the software layer between ERP and the shop floor. It dispatches work orders, runs the electronic batch record, captures real-time machine and process data, enforces material and equipment status, and pushes results back to ERP. In regulated industries it's also the system of record for contemporaneous, signed manufacturing data.
How is V5's MES different from Werum PAS-X, Körber, or Rockwell FactoryTalk?
V5 is pre-configured for regulated batch manufacturing and ships with eBR / eDHR, QMS, deviation, and calibration on the same platform. Implementations are 30 days to first signed batch, not 18 months. Pricing is in five and low-six figures, not seven.
Does V5 handle OEE and machine connectivity?
Yes — real-time OEE, machine downtime, scrap, yield, FPY, takt time. Connects to PLCs, scales, label printers, and barcode scanners.
Is the MES validated under GAMP 5?
Yes. Category 4 configured product, with CSA-aligned test evidence delivered at onboarding.
Can V5 MES run alongside our current ERP?
Yes. NetSuite, SAP, Dynamics 365, QuickBooks Enterprise, Sage X3, Infor — and others — via signed REST + webhooks.
See an MES that goes live before discovery ends.
Free trial. Real batches. No multi-year programme.