What’s new in Opcenter Execution Pharma 2505

Enhanced Operator Experience with Advanced Shop Floor Capabilities and Streamlined Process Management

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 2505, 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 direct 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 forward and backward search 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 2505 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

• Simplified manufacturing activities through real-time production data updates and integrated alerts in the Operator Cockpit
• Adaptable & extensible Operator Cockpit via low-code for a tailored best-fit user experience
• Improved Operational Efficiency with streamlined task management and enhanced Equipment Logbook functionality
• Greater Manufacturing Flexibility through extended weighing & dispensing capabilities and configurable process management
• Enhanced Performance Visibility with integrated OEE KPIs for data-driven production optimization
• Simplified Deployment and Maintenance with improved installation automation and database support

Capabilities

Operator Cockpit enhancements

• Integrated Alert operations:
  Production alerts can now be triggered and viewed directly within the Operator Cockpit, eliminating the need to navigate to separate applications. Operators can select tasks, trigger alerts, and document production events, with visual indicators clearly identifying tasks requiring attention.

• Real-Time Task List Updates:

The system now provides automatic refresh functionality, ensuring new tasks appear instantly upon creation, completed tasks are removed promptly, and task statuses update in real-time without waiting for scheduled refresh intervals.

• Upload annexes API:
  A new API enables the uploading of annexes linked to specific Work Orders, supporting more diverse use cases and providing a more streamlined user experience.

• Cyclic Operation multiple selection and reason code configuration

Operators can now select multiple Cyclic Operation tasks simultaneously and apply Pause or Resume actions with a single reason definition, improving efficiency and consistency in batch management.

Reason configurations are now manageable through a dedicated user interface, providing greater flexibility and control.

Benefits:

• Real-time production visibility for faster operations
• Streamlined workflow with consolidated application interactions
• Reduced operator task switching for improved focus and efficiency

Equipment Logbook enhancements

• Export logbook entries to PDF

Supervisors can now export filtered logbook entries to PDF/A format, supporting long-term archival requirements and compliance needs.

• Adaptive user interface

The logbook entry interface dynamically adjusts based on configuration, presenting additional attribute pages only when necessary, reducing operator interaction steps.

• Performance Optimization:

In addition to Oracle DB support, the Equipment Logbook application has been optimized to maintain high performance with large numbers of concurrent users and extensive databases.

Benefits:

• Regulatory-compliant documentation in industry-standard formats
• Streamlined data entry with fewer required interactions
• Consistent performance under high-demand conditions

Shopfloor integration enhancements

•  Extended Context Information:

Event PI context has been extended with RUP/ROP loop counter functionality, automatically populated by the triggering batch. This eliminates the need for custom scripts to retrieve this information, as business logic in the MES Process Instruction can now directly reference these values.

Benefits:

• Reduced configuration complexity and maintenance effort
• Improved system integration with fewer customizations
• More reliable data flow between shopfloor and MES systems

Process management & execution           

• Enhanced controls and traceability:

Electronic Signature capabilities now extend to PI-Item links, while alert creation requires additional identification, supporting multi-operator workstation scenarios without requiring logout between operations.

• Optimized Custom Tasklist (CTL):

The refresh mechanism for Custom Tasklists has been improved with self-managed updates and partial UI refreshes, enhancing performance and responsiveness.

• Extensible Weighing & Dispensing:

The Weighing & Dispensing module now offers greater adaptability through new user exits and custom rules, enabling use cases such as automated weighing mode selection, scale pre-selection, additional verification checks, enhanced printed information, and more.

Benefits:

• Improve traceability and control
• Enhanced operator experience with optimized interface responsiveness
• Support for specialized weighing and dispensing workflows beyond standard functionality

Improved serviceability, supportability and DAID

• Streamlined Installation:

Automated installation capabilities have been expanded for Application server and Presentation server profiles, complemented by new ANSIBLE playbook support for PostgreSQL database installation.

• Enhanced Deployment Tools:

DAID (Deployment, Architecture, Installation, and Design) package and documentation improvements reflect real-world implementation feedback and include example Oracle ANSIBLE playbooks that can be adapted for specific deployment scenarios.

Benefits:

• More consistent and repeatable installation processes
• Reduced deployment complexity and configuration errors
• Improved system maintenance and upgrades

Summary of Opcenter EX PH 2505 enhancements

Operator Cockpit

• Trigger & view alerts
• Upload annexes via API in PI Process
• Cyclic Operations; pause/resume multiple tasks at once, configurable reasons
• Automatic refresh & improved task list interaction
• Oracle DB support

Equipment logbook

• Logbook entries export in PDF
• UX experience streamlined
• Oracle DB support
• High availability enhancements
• Performance optimizations

Process management & execution

• Electronic signature integration for manual alerts
• Extended audit trail linking PI & Item
• Enhanced verification before eBR approval
• Optimized custom tasklist refresh mechanisms

Weighing & Dispensing

• Extended OOTB functionality via configurable user-exits
• Simplified configuration for remote weighing bar graph

Shopfloor integration

• Batch RUP/ROP counters as Event PI parameters

Serviceability & Supportability

• Enhanced setup traceability
• Improved Audit trail for setup module via command line
• Expanded automated installation capabilities
• PostgreSQL deployment via ANSIBLE playbook

This version also includes several upgrades to technical aspects, enhanced security and bug fixes.

Want to learn more? With Opcenter Execution Pharma Siemens Digital Industries Software has developed a dedicated MES solution for the pharmaceutical industry that enables complete paperless manufacturing and full electronic batch recording.

Opcenter Execution Pharma provides advanced features for designing, streamlining and managing production operations and processes – both manual and automated – via seamless integration between the MES, automation and enterprise resource planning (ERP) systems.

Find out more about Opcenter Execution Pharma.