MES software that an FDA inspector and a plant manager both sign off on.
V5 Ultimate is the MES regulated manufacturers run when their ERP module can't get past QA and their MES vendor can't quote under $4M. Dispatch, execution, signed batch records, OEE, deviations, calibration — one platform, one audit, one training footprint. Live in 30 days.
You're shopping for an MES because the gap between ERP and the shop floor has cost you a batch.
Your ERP says you have inventory the warehouse can't find
Operators run paper travelers next to a $40M ERP
OEE is a monthly PowerPoint, not a real-time signal
Last inspection cited contemporaneity or audit-trail depth
Your MES vendor wants 18 months and seven figures before go-live
Deviations get caught at end-of-batch, never at the failing step
Everything a regulated MES is supposed to do, configured before kickoff.
Work-order dispatch
Orders flow from ERP, get scheduled, hit the kiosk in the operator's hands — sequenced, gated, materials-bound.
Signed eBR / eDHR
Every step recorded contemporaneously, every signature bound to the record under 21 CFR Part 11 and EU GMP Annex 11.
Real-time OEE
Availability, performance, quality — by machine, line, shift. No spreadsheet. No month-end reconciliation.
Live deviation workflow
Out-of-tolerance, missed sequence, expired material — deviation opens at the failing step, pages QA, blocks the next step.
ERP + LIMS integrated
NetSuite, SAP, Dynamics, QuickBooks Enterprise, Sage X3, LabWare, STARLIMS. Signed REST + webhooks with idempotency.
Calibration + equipment
Calibration due-dates, instrument status, locked-out equipment — the MES knows what you can and can't use right now.
MES wins come from structure, not from buying screens.
- Cuts batch-record review time by 60–80%
- First signed batch live within 30 days of kickoff
- OEE visible to operators in real time — not in a Monday-morning report
- Eliminates the ERP-vs-floor inventory gap that kills release dates
- GAMP 5 Second Edition with CSA-aligned test evidence at onboarding
MES that holds up in every inspection regime.
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.
MES software, answered.
What is MES software?
Manufacturing execution system (MES) software is the layer between ERP and the shop floor. It dispatches work orders, runs the electronic batch record, captures real-time OEE, enforces material and equipment status, and pushes results back to ERP. V5 Ultimate is an MES with eBR / eDHR, deviations, calibration, and supplier quality bundled in.
MES vs ERP — what's the difference?
ERP plans and accounts; MES executes. ERP says you owe a customer 10,000 bottles by Friday. MES is what an operator uses on the floor to actually make them — signed, in-process-controlled, deviation-aware, audit-trailed. Your ERP probably has an MES module, but it almost never passes a Part 11 inspection. See our MES vs ERP guide.
Is V5 compliant with 21 CFR Part 11 and Annex 11?
Yes — natively. Bound e-signatures, hash-chained audit trail, RBAC with author-cannot-self-approve, authority checks. Validation evidence is delivered as part of onboarding.
Do you integrate with our ERP?
Yes. NetSuite, SAP, Dynamics 365, QuickBooks Enterprise, Sage X3, Infor, and others via signed REST + webhooks with idempotency keys. Scoping is hours, not months.
How long does an MES implementation take with V5?
Most plants run their first signed batch within 30 days. Multi-line rollouts are typically 8–16 weeks, depending on integration count.
See V5's MES run a real batch.
Free trial. No sales gate. First signed batch in 30 days.