In pharmaceutical manufacturing, demand for medicines continues to grow, while strict compliance with regulatory requirements remains essential. At the same time, manufacturers must maintain high product quality while improving operational efficiency to remain competitive in an increasingly demanding market.
Yokogawa addresses these challenges through the integration of its measurement, control, and information technologies. By combining Yokogawa's measurement and control solutions with TrakSYS, manufacturers can build highly efficient, GMP-compliant smart factories.
TrakSYS is a proven manufacturing execution and management platform. It also supports compliance with various regulations such as ALCOA++, GxP, FDA 21 CFR Part 11, EU Annex 11 and so on.
Empowering Manufacturing Excellence by Streamlining and Integrating Enterprise Workflow with MES.
Visualize Manufacturing Status in Real Time
- Provide a single, plant-wide view of equipment, line, and site performance in real time
- Analyze OEE and production KPIs in real time
- Immediately identify causes of downtime and losses
Digitalize Quality Management
- Monitor quality and detect deviations using SPC
- Support electronic records and electronic signatures
- Maintain audit trails
Achieve Complete Traceability of Products and Raw Materials
- Track history from raw material receipt to shipment
- Search information by lot or batch
- Achieve faster recall response and audit preparation
Standardize Manufacturing Operations
- Unify work procedures with electronic work instructions
- Automatically execute workflows
- Digitalize paper forms and reduce input errors
Connect with Existing Systems for Overall Optimization
- Connect with ERP, LIMS, eQMS, SCADA, and PLCs systems
- Provide scalability for multi-site deployment
- Enable rapid implementation through low-code/no-code configuration
Details
Visualize Manufacturing Status in Real Time
The system shows the operating status of equipment, production lines, and factories in real time.
OEE Dashboard
If OEE drops on a specific production line, users can check TrakSYS. They can see if the main cause is downtime, slow speed, or quality loss. This helps them decide which equipment or process needs improvement first. In daily meetings, teams can share improvement themes based on the latest dashboards rather than relying on paper-based summary sheets.
Digitalize Quality Management
The system captures quality data within manufacturing processes and supports the digitalization of quality management through SPC, electronic records, electronic signatures, and audit trails.
Quality Management with SPC
When managing temperature, pressure, and pH in a pharmaceutical plant, equipment data can be recorded automatically. Users can be notified right away when values fall outside the specified range. The detected deviation, together with the associated batch, equipment, and process data, is passed to the eQMS, where the formal deviation investigation and CAPA process is managed. Within TrakSYS, operators record the immediate on-site response according to electronic work instructions, and confirmation and approval histories are retained as electronic signatures. This helps prevent unauthorized changes to records and supports data integrity by maintaining traceable, tamper-resistant electronic records.
Achieve Complete Traceability of Products and Raw Materials
The system links data from raw material receipt through manufacturing, packaging, storage, and shipment, enabling bidirectional lot-level traceability through both trace-back and trace-forward.
End-to-End Batch Traceability Visualization
Quality checks may be needed for a specific lot after shipment. Users can review the product’s raw materials, equipment, operators, and process conditions on one screen.
Conversely, if a specific raw material is suspected of an issue, users can quickly identify product lots. They can also identify shipment destinations where that raw material was used. Because quality and manufacturing departments can investigate using the same data, the initial response can be accelerated.
Standardize Manufacturing Operations
Through electronic work instructions, workflows, and task management, the system standardizes work procedures and reduces dependency on individual expertise and paper forms.
Manufacturing Overview
In complex operations like product changeover or cleaning checks, TrakSYS shows operators the next task. It also lists required checkpoints and input items. Operators proceed according to the on-screen instructions and can enter measurement values or comments as needed. Even in processes where work quality tends to vary between new and experienced operators, standardized procedures help reduce variation.
Connect with Existing Systems for Overall Optimization
By linking to existing systems like ERP, LIMS, eQMS, SCADA, and PLCs, the system builds a strong base. It lets the same data be used from the shop floor to management.
Integrated Operations Management with TrakSYS
A production order created in ERP can move to TrakSYS. Operators on the shop floor can then do the work for that order. After completion, all relevant results are automatically shared back with ERP, including production quantity, raw material usage, work time, and quality results. This reduces duplicate entry and transcription errors and makes it easier to deploy common operating rules across multiple factories.
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