Siemens Opcenter Execution Pharma

Introducing Siemens Opcenter for MOM

Siemens Opcenter is a leading Manufacturing Operations Management (MOM) portfolio of software products aimed to enable all organizations to implement their strategies for the complete digitalization of manufacturing operations. Siemens Opcenter technologies and architecture were built to be flexible and easily adaptable to the specific requirements of different industrial processes – both in process manufacturing and discrete manufacturing. The highly scalable platform delivers powerful capabilities and enables manufacturers to combine production efficiency with production quality and production visibility to optimize their processes and significantly reduce their time-to-market.

Engineering Industries eXcellence has been working with the Siemens MOM offering for as long as it has existed. We have built a global team of business, technical, implementation and integration specialists with a level of expertise in these products that our customers could not find anywhere else in the world. Siemens Opcenter MOM solutions we deliver cover:

Advanced Production Planning and Scheduling
Manufacturing Execution Systems (MES)
Manufacturing Quality Management
Manufacturing Intelligence and Performance Management
Research, Development and Laboratory Management

About Siemens Opcenter Execution Pharma (SIMATIC IT eBR)

Within this Siemens MOM offering, Opcenter Execution is a portfolio of industry and process-specific Manufacturing Execution Systems (MES) designed to enable organizations to monitor, control and manage all the activities, resources and work-in-progress (WIP) on the factory floor and across their enterprise during the execution of production.

With Opcenter Execution Pharma (formerly known as SIMATIC IT eBR), Siemens has developed a dedicated MES for the Pharmaceutical and Life Sciences industry that enables complete paperless manufacturing and Electronic Batch Recording (EBR). Opcenter Execution Pharma provides advanced features for designing, streamlining and managing production operations and processes. It systematically controls execution at all stages, covering both human operations and operations controlled by the automation layer. Opcenter Execution Pharma provides real-time information about production, resources, processes and quality to help you optimize production activities starting from order creation all the way to the shipment of finished goods.

Embedding GAMP methodologies from the ground up, Opcenter Execution Pharma offers robust, pre-validated and pharma-specific capabilities which ensure that manufacturing processes are fully compliant with U.S. Food and Drug Administration (FDA) and Good Manufacturing Practice (GMP) regulations. Authorized users can design Master Batch Records (MBRs) containing all the specifications needed to automatically generate complete Electronic Batch Records for quality assurance (step-by-step processes for production, ingredients and components, verification of each step according to SOPs, electronic signatures, etc.). The system allows the review of the product batch record by exception, providing a faster and more efficient release of products.

By utilizing the key features of Opcenter Execution Pharma to drive the manufacturing process while tracking and collecting critical process and batch record data in real time, companies can increase quality and productivity while simultaneously reducing cycle times. Siemens Opcenter Execution Pharma also integrates with other enterprise systems including Automation & Controls, ERP, Production Planning & Scheduling, Product Specification Management, LIMS, Electronic Batch Record (EBR) Management, Quality Management and Manufacturing Intelligence.

Source: Siemens Opcenter Execution Pharma (SIMATIC IT eBR)

Target Manufacturing Sectors

Pharmaceutical manufacturing
Life science manufacturing
Biotech/biological manufacturing
Vaccine manufacturing
Nutraceutical manufacturing
Cosmetics manufacturing

Features of Siemens Opcenter Execution Pharma (SIMATIC IT eBR)

Track and monitor all work-in-progress (WIP), resources and activities on the factory floor
Synchronize production execution and operations across multiple sites
Collect operational data from production equipment and processes
Manage labor resources (activity reporting, time/attendance reporting, certification tracking, training records, tracing/prevention of unauthorized actions, role definition)
Guide and track personnel executing production with interactive work instructions, step validation and electronic signature requirements
Define equipment rules and properties
Track equipment usage and performance, and manage equipment maintenance
Track and manage the movement and storage of materials, in-process items and finished products
Facilitate and manage weighing and dispensing activities
Create and trace material samples and share results/analysis with integrated Laboratory Information Management Systems (LIMS)
Facilitate batch creation and definition process with integrated Electronic Batch Recording (EBR)
Real-time performance reporting against historic and/or expected results (resource utilization, resource availability, cycle times, conformance to schedule, SPC/SQC analysis based on parameters from control functions, etc.)
Monitor production processes and provide decision support to personnel to make improvements or corrections (within a single process and/or from one operation to the next)
Model alternative operations and pre-define workflows to overcome standard bottlenecks
Track and record production status and disposition of work in real time (personnel, materials, current status, alarms, rework, non-conformances)
Record production information allowing forward and backward traceability of components and their use within each batch (genealogy)
Track, record and centralize all information and validations required for the review of a completed batch record, enabling release by exception
Manage production order dispatching, sequencing, execution and changes
Access and update production documentation (work instructions, recipes, SOPs, batch records, laboratory/design change notices, etc.)
Schedule work orders, and define sequence and timing of operations based on priorities and rules associated with specific equipment and/or product traits
Pause a workflow execution until a predefined condition is met (e.g. pending laboratory analysis of collected samples)
Track and control quality throughout manufacturing process with focus on prevention and full compliance with ISA-95, GAMP 5, GxP, cGMP and 21 CFR Part 11 regulations and standards
Detect, sentence and/or repair non-conformances according to configurable rework processes
Allocate and control all resources utilized in manufacturing (equipment, tools, labor, skills, materials, procedures, documents, etc.)
Manage inventory (lot/container level), perform material calls and calls for replenishment
Integration with other enterprise systems (Automation & Control, ERP, Product Specification Management, LIMS, EBR Management, Quality/SPC, Manufacturing Intelligence, Production Planning & Scheduling, etc.)

Benefits of Siemens Opcenter Execution Pharma (SIMATIC IT eBR)

Achieve paperless manufacturing
Ensure complete Electronic Batch Records (EBR)
Full traceability of operations and materials
Significantly reduce batch review and release effort
Increase process and resource efficiency
Reduce rework and deviations
Facilitate research, development and laboratory efforts
Minimize cycle time
Optimize production activities in real time
Optimize equipment utilization
Increase manufacturing process visibility
Enable more informed decisions for production
Increase throughput
Synchronize processes in facility and/or across global enterprise

Our Partnership with Siemens Digital Industries

Engineering Industries eXcellence has achieved the Siemens Smart Expert Partner designation, which differentiates us as an industry and customer-validated expert in the Siemens Digital Industries software suite, specifically in their Digital Manufacturing products: Teamcenter Manufacturing, Shop Floor Connect (SFC), Shop Floor Integrate (SFI), Tecnomatix Plant Simulation, Tecnomatix Process Simulate, Opcenter Execution Discrete (SIMATIC IT UADM), Opcenter Execution Process (SIMATIC IT UAPI), Opcenter Execution Pharma (SIMATIC IT eBR), Opcenter Advanced Planning and Scheduling (Preactor APS) and Camstar. We are also certified in their Mendix and MindSphere Cloud solutions.

As a certified reseller, solution provider and system integrator for Siemens across several business units and portfolios, Engineering Industries eXcellence is the only Siemens partner in the world that has the combined vision, industry experience and technical expertise to deliver integrated solutions across all these different offerings.