Opcenter Execution Pharma

The platform to win the race against time provides electronic batch records (eBR) for the pharmaceutical industry

Overview Opcenter Execution Pharma enables more than paperless production: It’s the constantly evolving digital platform that helps pharmaceutical companies to develop and produce new drugs and vaccines faster than ever.

Time is precious and quality is essential

The orchestration of development and production in the pharmaceutical industry requires a powerful manufacturing execution system (MES). Opcenter Execution Pharma seamlessly integrates MES functionality, automation, and enterprise resource planning (ERP) systems. It enables you to streamline processes and operations in full compliance with regulations thanks to complete paperless manufacturing and full electronic batch recording. In short: It’s the decisive tool for greater competitiveness.

Speed up operations through paperless manufacturing and eBR apps

Faced with growing cost pressures, regulatory, safety guidelines and diverse product portfolios, pharmaceutical manufacturers are continuously looking for ways to improve production processes.

Our proven electronic batch record solution enables completely paperless manufacturing within regulated processes - and supports from the design of the batch record to the release of the batch report.

Benefits Design, guide, control and review the product and production lifecycles by providing an electronic batch record that precisely details how a drug has been produced as required by FDA, CFDA and European regulatory bodies.

Opcenter Execution Pharma optimizes processes without IT skills

Design

Develop, use, and reuse standard processes and sub-processes through an intuitive tool. There are no IT skills required.

Opcenter Execution Pharma enables paperless manufacturing

Execute

Benefit from faster and safer data acquisition thanks to a guided and controlled paperless process.

Review

There’s a single point of review of all batch relevant information, which ultimately enables review by exception.

Functional overview

Master batch records (MBR)

Graphical workflows, text editor design, pre-built work elements, and parameter management

Material management

Inbound process (goods receipt, sampling, QC), picking and requisitioning, tracking and tracing, and outbound process (goods issue, shipping)

Weighing and dispense

Scale management and calibration check, 16 predefined weighing methods, tolerance, potency and density calculations, check in/out of prepared materials

Enterprise integration

Interface to other business and manufacturing systems, standard connectors, integration with Opcenter APS and Opcenter Laboratory

Electronic batch record

Guidance and electronic instructions, compatible with tactile environment, real-time control, deviation management and release by exception

Equipment management

Classes and properties, fixed, mobile, single use or reusable, advanced life cycle configuration, equipment logbook

Packaging

Line management instructions, in process quality control, material replenishment, concordance calculation and reconciliation

Automation integration

OPC and OPC UA client, integration of MES task list in HMI, native integration with SIMATIC PCS7 and SIMATIC Batch

Providing eBR as a managed service

The goal for future releases of our eBR Apps Suite is to provide eBR services and apps. We want to make the deployment of a paperless batch record system more affordable through cloud-based infrastructure. Moreover, we’re going to enable you to build new apps with a low-code application development platform.

Enabling the next generation of paperless manufacturing

Our eBR App Suite enables batch review on mobile devices like smart phones and tablets, so you can receive batch information, record manufacturing tasks, and build equipment records. You can use biometric authentication, which is secured by centralized user management and compatibility with General Data Protection Regulations. The eBR App Suite consists of three distinct apps: eBatch Operator for reconciliation, compounding and equipment management; eBatch Reviewer to review batches directly on mobile devices in real-time; and eLogbook Manager to easily access logbooks from anywhere. The Suite lets you improve quality and reduces time to react after a deviation, enables remote shift management and control, enhances key user interaction, reduces cost of software ownership, and facilitates review by exception, focusing on relevant data only.

Computer with microbiology virus expertise on display standing on table during biochemistry experiment in biological hospital laboratory

Discover, what’ new in Opcenter Execution Pharma

Opcenter Execution Pharma version 2211 introduces several enhancements, including the optimization of paper usage until all processes can be handled electronically, the reduction of development efforts and risks by integrating MES and DCS. It supports the standardization and harmonization of processes, facilitates the implementation across sites, and makes batch-relevant information reviews faster and safer.

Using Opcenter Execution Pharma enables manufacturers in the life sciences industries to achieve operational excellence, accelerate time-to-market, reduce compliance costs, and improve quality and productivity.

Download PDF

Infocenter Learn more about our solutions with a variety of documents, videos and downloads.

Contact

Get in touch with our experts

Would you like to learn more about Opcenter Execution Pharma and its use cases? Don’t hesitate to contact us. Our experts are looking forward to supporting you.