What’s new in Opcenter Execution Pharma 2605
Expanded Web-based Operator Experience with AI-powered Design, Enhanced Platform Performance and Modular Weighing
Summary
Opcenter™ Execution Pharma (EX PH) software serves as the foundation for leading pharmaceutical manufacturers and innovators that want to enable rapid change, lean paperless manufacturing, consistent quality output, and higher profit margins. Offering native integration between the manufacturing execution system (MES) and the distributed control system (DCS) layer, Opcenter EX PH expedites the design, execution and review of the manufacturing process steps and provides flexibility in the master batch record (MBR) design process.
Opcenter EX PH 2605, which is a part of the Siemens Xcelerator business platform of software, hardware and services, enables users to regulate and manage processes without paper-based procedures or documents. With Opcenter EX PH, you can easily configure and leverage out-of-the-box (OOTB) functionality to facilitate design processes even if the user does not have specific information technology (IT) skills.
Powered by an advanced workflow engine and easy-to-use electronic work instructions (EWIs), manufacturers can use Opcenter EX PH to drive manufacturing while recording and centralizing everything required for a completed batch record. Further, leveraging MBRs facilitates managing key process parameters.
As the system is fully compliant with U.S. Food and Drug Administration (FDA) and Good Manufacturing Practice (GMP) regulations, manufacturers can optimize batch manufacturing processes and streamline resources such as user guidance, equipment allocation, and standard operation procedures (SOPs). The software can also systematically control the manufacturing execution at all stages, including human operations or operations controlled by the automation layer.
Using Opcenter EX PH enables manufacturers to reliably acquire critical process data. Additionally, users can search forward and backward using the genealogy and audit trail tools; and review product batch records by exception to provide faster and more efficient product releases. This significantly reduces the manufacturing review and release times, and facilitates a faster time-to-market.
Opcenter EX PH 2605 includes several enhancements, delivers new OOTB features, eases the engineering requirements and reduces the total cost of ownership (TCO) of a customer’s system.
Benefits
- Execute an expanded scope of manufacturing instructions directly in the web-based Operator Cockpit
- Improve engineering productivity with AI-powered design capabilities
- Boost system performance and scalability through core, database and API optimizations
- Reduce deployment and operational effort with simplified configuration and AI-assisted support
- Enable flexible weighing execution through a modular web-based framework.
Capabilities
Web-based Operator Cockpit and Web EWI extensions
Opcenter Execution Pharma 2605 strengthens the web-based operator experience by enhancing both Web-based Work Instructions and the Operator Cockpit. This release continues the transition from paper-on-glass toward fully paperless execution, enabling operators to perform, monitor and review manufacturing tasks within a modern browser-based environment while maintaining compliance, traceability and usability.
The batch record scope is extended with additional execution capabilities, allowing a broader range of manufacturing instructions to be executed directly in the web environment without requiring a redesign of the existing configuration.
The Web-EWI introduces support for list-based, labelling and barcode identification, as well as alert tags. Electronic signature handling is reinforced for forced values and tolerance deviations, combined with improved access control.
Usability and performance have also been enhanced through features such as keyboard shortcuts, automated installation improvements and optimized API communication.
In parallel, the Operator Cockpit benefits from enhanced task execution capabilities. Operators now have access to detailed execution views and full history tracking, improving visibility and control over manufacturing activities. Performance improvements ensure better responsiveness and scalability, while annex reporting capabilities have been extended to support more efficient review processes.
Key benefits
- Accelerates adoption of paperless manufacturing with full browser-based execution
- Improves operator efficiency through enhanced usability and visibility
- Strengthens compliance with improved electronic signatures and traceability
- Reduces IT complexity through web-based architecture and simplified deployment
Smart Operation Designer: AI-powered EWI and Operation Design
Smart Operation Designer introduces a major step forward in engineering productivity by bringing AI-assisted capabilities into the design of Electronic Work Instructions and operations. It enables organizations to transform legacy process documents into structured and executable manufacturing instructions.
With this release, users can leverage AI-powered PDF processing to extract and structure process information from existing documentation, significantly accelerating the digitalization of paper-based procedures. The integrated copilot assists users in refining and adapting generated instructions, supporting interaction with the EWI model in a more intuitive and efficient way.
The introduction of template-based Electronic Work Instruction and operation routing design enables a standardized and reusable approach, ensuring greater consistency across projects and sites while reducing engineering effort.
The app allows the designer to import the workflow for the EWI from an external BPMN file. The operating blocks in the workflow can be associated with the steps in the EWI.
Finally, the data (EWI along with all its images + Workflow) can be downloaded so that a downstream MES can import it and execute it.
Key benefits
- Reduce engineering effort through AI-assisted document conversion
- Accelerate digital transformation from documents-based to executable processes
- Improve standardization through template-driven design
- Prepare for evolution toward advanced Opcenter architectures
Web-based Weighing and Dispensing: Modular and Extensible Weighing Framework
This new solution introduces a modern, modular and extensible approach to weighing and dispensing, fully integrated into the Operator Execution Pharma. It is designed to progressively expand the coverage of the legacy rich client Weighing application through next releases.
In 2605, the web-based application can already be used for supported use cases, while the existing rich client application remains available for more advanced or not yet covered scenarios. This complementary approach enables a smooth and controlled transition toward a fully web-based solution.
The web weighing engine is designed to be adaptable to different use cases and supports extensibility through configurable steps and modes. A library of predefined weighing steps is provided, covering key activities such as material selection, scale interaction, weighing execution and label printing. Out-of-the-box weighing modes include Manual and Net, enabling rapid adoption without additional configuration.
This app features a modern UX, including a bar graph updated in real-time thanks to balance communication (via Mendix Workstation).
Key benefits
- Improves flexibility to adapt weighing processes to site-specific needs
- Enhances operator productivity through guided execution
- Enables faster deployment through modular and extensible architecture
- Provides a scalable foundation for future enhancements
Process Management and Execution
Release 2605 enhances process execution capabilities and strengthens system integration, enabling more flexible and efficient production management.
Manufacturing declaration now supports operations with manufacturing lots in any status, allowing more advanced and adaptable execution scenarios. Container updates have been improved through XSI integration, ensuring more reliable data handling and integration with external systems. In addition, Process Instructions can now be imported via API using standardized file formats, simplifying system interoperability.
Key benefits
- Increases flexibility in production execution
- Simplifies integration with external systems
- Reduces manual effort through improved automation
Performance, Serviceability and Platform Enhancements
Opcenter Execution Pharma 2605 delivers significant improvements in performance, scalability and system operability, ensuring the platform can efficiently support increasing workloads and complex environments.
Core applications (PI Service and PI Process) have been optimized to drastically reduce ORACLE CPU and I/O consumption improving system responsiveness. These improvements are reinforced by complementary optimizations at database and execution level, including metadata table optimization to prevent unnecessary records from being stored, thereby reducing database growth, as well as task report enhancements that eliminate reports in loop previously impacting CPU and memory usage, resulting in additional performance gains. API performance has also been enhanced through the introduction of event-driven communication mechanisms, reducing reliance on polling approaches.
The release also introduces an AI-based documentation assistant to improve access to product knowledge thereby accelerating user support. In parallel, system configuration has been simplified through improved parameter management and enhanced installation and deployment processes.
Key benefits
- Improves system scalability and responsiveness
- Reduces total cost of ownership through optimized resource usage
- Simplifies operations and maintenance
- Enhances user autonomy with AI-assisted documentation
Summary of Opcenter EX PH 2605 enhancements
Web-based Operator Experience (Web EWI & Operator Cockpit)
- Extended batch record scope with new tags (list, labelling, barcode identification, alerts)
- Enhanced electronic signatures and improved usability (keyboard shortcuts, web execution performance)
- Improved Operator Cockpit with task execution details, history tracking and annex reporting
Smart Operation Designer
- AI-powered PDF processing for conversion of legacy documents into Electronic Work Instructions
- Copilot-assisted design and template-based EWI and operation routing
- Standardized and reusable engineering approach
Web-based Weighing and Dispensing
- Library of configurable weighing steps and out-of-the-box modes (Manual, Net)
- Progressive coverage approach coexisting with the legacy application
- Extensible integration with shopfloor devices
Process Management and Execution
- Manufacturing declaration with support for production lots in any status
- Container updates via XSI
- Process Instruction import via API (.cab files)
Serviceability, Performance and Platform Enhancements
- Core service optimization reducing ORACLE CPU and I/O consumption
- Metadata and task report optimizations improving database efficiency and execution performance
- Event-driven API communication reducing reliance on polling
- Simplified system parameter management and installation
- AI-powered documentation support
This version also includes several upgrades to technical aspects, enhanced security and bug fixes.
Find out more about Opcenter Execution Pharma.
