Need for this

Pharmaceutical manufacturing operations are increasingly reliant on accurate and timely data from shop floor devices to ensure product quality, regulatory compliance, and operational efficiency. However, traditional methods of capturing this data involve manual entry, which is error-prone, time-consuming, and non-compliant with modern data integrity expectations. In manufacturing, capturing accurate, real-time data from various shop floor devices (balances, sensors, RFID readers, etc.) is crucial for ensuring:
Data integrity according to ALCOA+ principles
Reduced manual errors in transcription and entry
Seamless compliance with 21 CFR Part 11 and other regulatory standards
Real-time decision making based on device data
Faster batch execution without delays in data capture
Benefits of Implementing DCube
DCube acts as a middleware engine that connects shop floor devices directly with the ProcessXE MES layer, offering:
Real-time device data capture into MES workflows
Supports multiple protocols: RS232, TCP/IP etc.
Any device integration across various instruments, equipment, sensors and signals etc.
Eliminates manual data entry and enhances operator efficiency
Enables data validation at source level and flags out-of-spec results
Reduces reporting time per batch by automating readings
Centralized logging for audit and traceability
Process Diagram
1
Information gathering: Transmits raw process data (i.e., weight, environmental readings, identification codes etc.) from shop floor devices (RFID, Balances, pH meters, temperature sensors etc.)
2
Data processing through DCube: Decodes raw device signals into readable values and maps data to specific MES parameters or process steps
3
Execution: Automatically record the data in real-time with timestamp, user details and device information enhancing DI and complying with regulatory requirements.
DCube with ProcessXE ®
Plug & Play Integration Devices are configured with DCube without additional drivers or coding.
Auto-Decode and Map Raw device data is decoded and mapped into defined MES data fields.
Rule-based Validation DCube applies rules (e.g. expected range, material match, specification limits etc.) to ensure only valid data is accepted.
Audit Trail & Timestamping Every data point captured is tagged with timestamp, user ID, and device ID ensuring full traceability.
Device Monitoring Health check signals and connection status of devices traceability.