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SMART FACTORY
Manufacturing execution systems built to each industry's processes and regulations
Questions this page answers
- How is an MES configured for our industry's processes and regulations?
- Can an MES be built while keeping existing equipment and ERP?
- What is required to digitize GMP batch records?
- In what order should MES and AI be adopted?
Record requirements differ by industry
Automotive parts require forward and backward tracing of material LOTs and component serials tied to each assembly number. Health functional food requires batch splitting, weighing records and batch record approval. Cosmetics filling lines measure output against each machine’s standard speed; injection processes keep the mould and the process conditions together.
Where processes and regulations differ, screen composition and workflow differ with them. IMPIX has built its MES separately by industry.
MES by industry
| Industry | Scope | Core functions |
|---|---|---|
| Automotive parts | 96 screens · 12 menu groups | Forward and backward LOT tracing across machining and assembly, component serials tied to assembly numbers, OEE and MTBF/MTTR, around 20 ERP and QMS interfaces |
| Health functional food | 111 screens · 13 top-level menus | Batch splitting for powder, liquid and softgel lines, weighing and dispensing, electronic batch record approval, LIMS test integration |
| Cosmetics | 30 screens · 9 menu groups | LOT output across filling and packaging, automatic quantity counts from sensor data, 3D plant model monitoring |
| Plastic injection | 61 screens · 8 menus | Daily work logs by machine and mould, hold cards for defect quarantine, self-inspection, raw material moisture history |
Pharmaceutical and bio plants are configured with EBRS and REMS.
POP — shop-floor terminal
A terminal beside the line records every event from job start to finish. Work orders and master data come from the MES; output, downtime, equipment faults and LOT history are returned to the MES and ERP.
Running, waiting, downtime, equipment fault and complete are tracked as distinct states, with operating hours totalled automatically. The terminal supports material LOT barcode input, transfer cart label issue, work standard and Q-Point lookup, and equipment fault reporting with photo attachment.
EBRS — electronic batch records
Master batch records are designed as electronic forms and approved by production and quality management. A batch record is issued per batch, capturing floor work, weighing, equipment use and inspection under electronic signature.
- ID and password re-entry for signatures at process start and finish
- 29 logbooks and checklists
- Audit trail across 16 categories
- Logical deletion with recorded reason (remark)
- Batch record review, return review and approval; executed batch record report output
- Data collection from electronic scales and historian; ERP and WMS interfaces
REMS — cleanroom environment monitoring
Temperature, humidity, dew point, differential pressure and airborne particles are collected in real time from sensors and the building management system.
The floor plan displays four states: normal, warning, deviation and communication failure. Temperature and humidity limits are set per process and product, and positive or negative pressure limits per differential pressure point, with a delay time applied to exclude momentary variation before a warning or deviation is declared.
Each deviation records the action taken and the reason. User and system changes are written to the audit trail with before and after values, and file download history is retained.
Monthly and daily statistics, seasonal and time-of-day averages, and air handling unit to room correlation are analyzed. The daily monitoring report is generated automatically and SMS alerts are sent by team.
System integration
Equipment data is collected over OPC-UA and mapped to the AAS and KS X 9101 standards, bringing values in different formats — conveyor alarms, nut runner torque, scale readings — onto a single scheme.
ERP, QMS, WMS and LIMS connect through interfaces. The automotive parts MES carries around 20: receiving work orders, BOM, items and equipment, and sending output, traceability and shipping. Existing systems are not replaced.
Process data and internal documents remain on-premise.
Control permissions
Equipment control permissions are granted separately by action.
| Action | Default |
|---|---|
| Reading production line equipment PLCs | Permitted |
| Batch completion approval and electronic signature writes | Permitted |
| Process recipe control command writes | Blocked |
Writes that change a process recipe are blocked by default and opened by separate agreement.
Fields of application
Built across pharmaceutical and bio, health functional food, cosmetics, automotive parts, consumer goods and materials, including MES delivery at overseas plants.
- Pharmaceutical and bio — GMP batch record digitization, continuous cleanroom monitoring, audit response material extraction
- Health functional food — Batch and weighing records on powder, liquid and softgel lines; electronic batch record approval
- Cosmetics — Automatic LOT output counts on filling and packaging lines; utilization and downtime cause analysis
- Automotive parts — Bidirectional LOT tracing across machining and assembly; maintenance plan and record management
Order of AI adoption
With an MES in place, process records accumulate in a standardized form. That data collects in B²LAB, and A²LAB builds quality prediction and predictive maintenance models on top of it.
Applying AI before the records are standardized makes it difficult to explain what the model learned from.
Components and key capabilities
- MES by industry
- Automotive parts, health functional food, cosmetics and plastic injection each have different processes and record requirements, so each is built separately.
- POP — shop-floor terminal
- Records job start to finish at the line terminal. Takes work orders from the MES and returns output, downtime, equipment faults and LOT history.
- EBRS — electronic batch records
- Master batch records are designed and approved as electronic forms, with a record issued per batch under electronic signature and audit trail.
- REMS — cleanroom monitoring
- Collects temperature, humidity, dew point, differential pressure and airborne particles in real time and adjudicates warnings and deviations against GMP limits.
- Existing systems retained
- Equipment data maps to OPC-UA, AAS and KS X 9101, with interfaces to ERP, QMS, WMS and LIMS.