What is the Pharmaceutical
Level 4 Integration System?
The Pharmaceutical Level 4 Integration System connects field operating systems with high-level business systems to ensure synchronized data flow across all operational levels according to the ISA-95 standard, achieving unified operational visibility and full regulatory compliance inside and outside the facility.
Why is the Pharmaceutical Level 4 Integration System Essential for Every Pharmaceutical Facility?
Unified Operational Visibility
Connecting production, quality, warehousing, and distribution within a single platform.
Reduced Manual Intervention
Full automation of reporting, verification, data transmission, and traceability operations.
Enhanced Compliance
Significant reduction in data, reporting, and traceability errors.
Regional Expansion Readiness
Supporting the requirements of Gulf, European, and regulated international markets.
Pharmaceutical Level 4 Integration System Architecture According to ISA-95
The integration is built according to the approved industrial architecture to ensure data flow across all operational levels.
Levels 0 to 3
Including PLC, SCADA, cameras, printers, serialization stations, and packaging machines.
Level 4
Including enterprise resource planning, manufacturing execution, warehouse management, and quality systems.
Traceability and Regulatory Compliance Platforms
Including SFDA RSD, UAE Tatmeen, and regulatory cloud platforms.
Compliance Architecture
Fully aligned with ISA-95 standards ensuring end-to-end traceability across all integration levels.
Supported Systems in the Pharmaceutical Level 4 Integration System
SAP S/4HANA
Direct integration with production, warehouse, quality, and shipping systems.
Oracle ERP
Full support for serialization, EPCIS reporting, SSCC, and regulatory reporting operations.
Microsoft Dynamics
Real-time linking of operational and logistics data.
How Does the Pharmaceutical Level 4 Integration System Work?
Integration
API Integration
Connecting systems via REST, SOAP, Middleware, and Enterprise Connectors.
EPCIS Reporting
Transmitting traceability and serialization data according to GS1 EPCIS standards.
Real-Time Synchronization
Instant synchronization with SFDA RSD, UAE Tatmeen, and Gulf traceability platforms.
Automated SSCC Generation
Automatic creation and management of SSCC codes, aggregation hierarchies, and shipment data.
What Sets Automera Apart in Implementing the Pharmaceutical Level 4 Integration System
Specialized Expertise in Industrial and Pharmaceutical Integration
Automera brings deep expertise in designing pharmaceutical integration architectures according to the ISA-95 standard, with full knowledge of SFDA requirements and serialization in pharmaceutical manufacturing environments.
Integration Architecture Tailored to Your Technical Environment
Every integration project is designed based on existing systems, compliance requirements, and operational scale, ensuring seamless integration without disrupting operations.
Continuous Monitoring and Ongoing Technical Support
Full commitment to monitoring integration performance, detecting any issues, and improving system performance post-commissioning to ensure continuous data flow and regulatory compliance.
Frequently Asked Questions
- What is the communication protocol with the SFDA system?The system supports communication via EPCIS standards, secured APIs, and GS1 standards to ensure full compliance with regulatory requirements.
- How does the system handle traceability event reports?Traceability events are automatically generated and transmitted, linked with serialization, aggregation, shipment, and warehouse management operations.
- Can the system integrate with a custom ERP?Yes, integration is possible with any ERP system or operational platform that supports APIs or operational databases.
Your facility deserves smart and seamless integration
The Automera team is ready to build the right Pharmaceutical Level 4 Integration architecture for you.
