Manufacturing Execution System · MES · GMP MES
A manufacturing execution system for regulated production, set up around your process.
Work orders, electronic batch records, OEE, deviations and calibration on the same platform as your quality records, with ERP connections scoped with you.
Work orders to the floor
Dispatch work orders and run each step at a kiosk.
Records as you go
Batch records, readings and signatures captured at the step.
Quality on the Same Platform
Deviations, calibration and OEE sit beside the batch.
Plan
A planner releases the work order with its recipe version and materials.
Your recipe, steps and review rules are configured with you.
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
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.
A modern MES rewires the floor, not just the screens.
- 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 — software controls that support your Annex 11 approach; validation and procedures remain yours.
Building medical devices? See the device history record page.
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. 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.
Can V5 MES run alongside our current ERP?
Yes.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
See an MES that goes live before discovery ends.
Free trial. Real batches. No multi-year programme.