Released WO-9021 to line 2 with the traveller attached.
Routing Rev C · materials staged · lot 224-B
Manufacturing Execution System
What happened on the floor.A record, not a memory.
Work orders, electronic travellers, inspection, and batch records on one system, so every operation is signed, evidenced, and traceable by lot.
One governed record across regulated production
- Medical Devices
- Pharmaceuticals
- Cosmetics
- Food Processing
- Automotive
- Aerospace
Paper travellers can’t prove what happened on the line.
Built at the operation, the batch record answers every question about the run.
- Batch record assembly
One batch, four records, no truth
4 parallel records of one batch.One record, built at the operation. Steps, consumption, and checks land as they happen.
How they handled it · 6:33Harmonic Bionics - Inspection binding
The wrong revision inspects the lot
Memory binds the check to the order.Checklist bound to the order. The right revision arrives with the order. No memory required.
How they handled it · 1:01Dave Anderson - Lot traceability
The recall runs on spreadsheets
Hand-built genealogy, assembled under recall pressure.Genealogy already linked. Inputs, parameters, and dispositions linked as the lot moves.
How they handled it · 0:48Biovation Labs - Shift handoff
The rationale leaves with the shift
Lost decision rationale between shifts.Rationale on the record. Who decided what, and why, signed onto the batch.
How they handled it · 1:11Dave Anderson
Five disciplines, one shop floor.
The work order, the traveller, the inspection, and the batch record stay connected from release to a sealed, traceable lot.
Work Order Management
The floor runs to plan.
Open, schedule, execute, and close work orders on the shop floor, with their operations on the record.
- Opened, scheduled, released to the floor
- Operations and quantity on the record
- Live status per operation and station
- Closed with its full history
ISO 1348521 CFR 820IATF 16949
eTravellers
The record builds itself.
Electronic travellers that replace paper batch and route sheets, capturing step completion, evidence, and signatures at each operation.
- Replaces paper batch and route sheets
- Step completion captured at the operation
- Evidence bound to each step
- A signature on every operation
21 CFR Part 1121 CFR Part 211EU GMP
FAI & Control Plan Execution
First article, proven.
First Article Inspection and ongoing control-plan execution on the floor, with results capture, disposition, and escalation.
- First Article Inspection on the floor
- Control-plan checks at frequency
- Results captured with disposition
- Escalation when a check fails
IATF 16949ISO 1348521 CFR 820
Inspections, Forms & Checklists
Checks where the work is.
Configurable inspection forms and checklists executed at defined points in the workflow.
- Configurable forms and checklists
- Fire at defined workflow points
- Results land on the record
- A failure holds the line
ISO 1348521 CFR 820EU GMP
Electronic Batch/Lot Records
Traceable by lot.
Electronic batch and lot records with QR-code generation for traceability through manufacturing and distribution.
- Built as the work is done
- QR codes per batch and lot
- Reconciled, then sealed
- Traceability through distribution
21 CFR Part 211EU GMP21 CFR Part 11
The controls a shop floor runs on.
Step-level signatures
Every operation carries the operator, the evidence, and the signature that completed it.
Lot traceability
QR-coded batch and lot records follow the product through manufacturing and distribution.
Control-plan execution
First article and ongoing control-plan checks run on the floor, with disposition and escalation.
Configurable inspections
Inspection forms and checklists fire at defined points in the workflow, not off to the side.
Work order to close
Work orders are scheduled, executed, and closed with their operations on the record.
Deviations at the point of use
An operator raises a deviation or quality issue from the operation, and it holds the work.
From a released work order to a sealed batch record.
Follow the work through the lifecycle.
Works with the systems you already run.
Connect the shop floor to the systems already holding your orders, lots, and specs.
- SAP
- Oracle NetSuite
- Epicor Kinetic
- Infor CloudSuite Industrial
- SYSPRO
- Microsoft Business Central
- Scheduled CSV Import
For the people who run the shift.
From the released order to the sealed record, every role signs the same lot.
Production Supervisor
OwnsReleasedClosed
- Hold start-of-shift, assign work
- Sign batch and lot records
- Coordinate holds, downtime, and deviations
Shop Floor Operator
OwnsIn processSigned
- Execute steps, record results electronically
- Flag deviations, respond to quality holds
- Record downtime at the equipment
Quality Inspector
OwnsInspectionRelease
- Perform inspections to plan, sample against AQL
- Raise non-conformances, segregate failing material
- Release passing material, hold the rest
What operations teams say when the record builds itself.
Short, candid accounts of lot release, travellers, and floor-level traceability from the people running production.
Biovation LabsJesse Kolstad, Director of QualityFinished-good lot release, from days to minutes
Harmonic BionicsClarissa ArcherCerts, lot and PO numbers, and inspection on each lot
Mikala HukkaFinished-good lot process, half a day to 10 minutes
Harmonic BionicsDenis MachokaMaterial consumed at each station, flagged if on hold
Biovation LabsJesse Kolstad, Director of QualityMock recall done in 18 minutes against a 4-hour window
Seth BozmanConstruction15 remake cards in 15 minutes, not an hour and a half
One governed shop floor. Every standard.
Sign the operation once, then prove it against whatever governs your production.
- FDAFDA · US
21 CFR Part 11
Trustworthy electronic records and signatures.
- FDAFDA · US
21 CFR Part 211
cGMP for finished pharmaceuticals.
- FDAFDA · US
21 CFR 820
Quality System Regulation for device cGMP.
- ISOISO · Global
ISO 13485
QMS for medical devices.
- IATFIATF · Global
IATF 16949
QMS for automotive production.
- EUEC · EU
EU GMP
GMP for medicinal products (EudraLex Vol. 4).
Validated across
- Medical Devices
- Pharmaceuticals
The questions operations and quality ask first.
Anything else, bring it to the walkthrough.
Five modules on one system: Work Order Management, eTravellers, FAI & Control Plan Execution, Inspections/Forms & Checklists, and Electronic Batch/Lot Records with QR Codes.
Release the lot. Keep the record.
Bring the batch record you rebuild by hand and watch one lot run from work order to a sealed, signed record in a 30-minute walkthrough.