Complete batch records, no goods left waiting
Traceability by serial number and lot; batch record data is captured during production, so finished goods don't sit waiting for paperwork.
Common problems
Finished goods waiting for paperwork
Batch records are compiled after production, and goods sit waiting for approval.
Manual batch records
Handwritten, copied over, prone to missing signatures and wrong figures.
Traceability by serial number and lot
Regulations and customers require tracing each unit back to its materials, machine and operator.
Materials by lot and expiry date
Material lots must be used in the right order, before they expire.
Root causes hard to find
When a defect appears, it takes days to dig through paper records.
Multiple inspection points
Incoming, in-process and final inspection must be recorded completely and on time.
Following the flow of the plant
Raw material warehouse
Receive by lot, with expiry date and incoming inspection results; issue by work order.
Production
Output, downtime and operator recorded by work order at the machine.
In-process inspection
Inspection results recorded on the spot, linked to the running lot.
Packing
Each unit and each carton gets a serial number or lot code at packing.
Batch record
Production and inspection data for the lot compiled from the system, not copied by hand.
Finished-goods warehouse
Ship by order; trace back from serial number to material lot, machine and shift.
Modules for medical devices
The full set of ControlMES modules is available, configured for medical devices. Deploy them one at a time or together, as your factory needs.
| Module | In a medical device plant |
|---|---|
| Master data | Item codes, materials, process steps, production standards, defect lists and inspection criteria. |
| Planning & scheduling | Plan by lot and machine; know which lots will make their due dates. |
| Production tracking | Output, downtime and operator for every work order. |
| Inventory & material flow | Materials by lot and expiry date; issued by work order. |
| Quality management | Incoming, in-process and final inspection; defects by code, linked to the lot. |
| Machine connectivity | Output and run/stop status taken from the machines. |
| Traceability | From serial number or lot code back to materials, machine, shift and operator. |
| Management reporting | Lot progress, defect rates and goods waiting for paperwork across the plant. |
| Maintenance | Planned equipment maintenance; maintenance history per machine. |
In operation
ControlMES is running at a medical device plant.
FAQ
Finished goods still waiting for batch records?
Production and inspection data is recorded at the machine as work happens and compiled by lot in the system.
Handwritten records full of errors, copied over and over?
Inspection results are entered on screen against predefined criteria, not copied from paper.
Tracing a defective unit back to its materials takes days?
From a serial number or lot code, trace back to materials, machine, shift and operator in minutes.
Materials used out of expiry order?
Materials are managed and issued by lot and expiry date.
Contact
A 1-day assessment at your medical device plant, free of charge: we follow one lot from the raw material warehouse until its batch record is complete.