Werum PAS-X MBR Design & Execution: Creating and executing master batch records

Does your production process involve highly complex manufacturing specifications? With PAS-X MBR Design & Execution, you can easily create your recipes (Master Batch Records), process them securely, and ensure compliance-compliant documentation.

Werum PAS-X replaces paper-based MBRs with electronic documents. As a result, time-consuming and error-prone manual comparisons and approval procedures are eliminated. With Werum PAS-X, you can shorten your approval cycles, reduce production efforts and cut costs.

Werum PAS-X easily integrates into your processes via standard interfaces to all leading ERP systems.

Easy to operate graphical structures

The MBR module of our software maps your Master Batch Records as graphical structures that are being easily handled on screen. 

Werum PAS-X also manages approvals completely electronically. You control the digital release processes with the help of role-based workflows. PAS-X supports all required review and approval workflows via e-mail directly to your desk. Users can enter and document corrections and changes in the system. Your manufacturing documents are automatically version managed.

To be sure that everything is still correct after changes have been made, Werum PAS-X MBR performs plausibility and completeness checks when creating the master batch records. To do this, you can apply more than 50 different check criteria. For example, the solution checks whether the recipe specifies all necessary process setpoints. If information is missing at any point, the system draws attention to the error.

Digital execution and documentation

Efficient electronic and thus paperless batch documentation is one of the main goals when introducing manufacturing execution systems in pharmaceutical and biotech production. Werum PAS-X electronically executes manufacturing regulations and documents processes and results in compliance with legal requirements.

Werum PAS-X ensures error-free and guided execution of the entire production process and right-first-time manufacturing. As a result, PAS-X MBR Design & Execution improves the quality of products and processes by up to 98 percent — right from the first use.

Seamless integration of Werum PAS-X

The value chain of your pharmaceutical or biopharmaceutical production thrives on a manufacturing execution system that fits seamlessly into it. Ideally, this system independently integrates all processes and machines to ensure smooth production. This is precisely what Werum PAS-X MES from Körber does. It allows horizontal and vertical integration into your infrastructure via clearly defined standard interfaces. After implementation you will be able to seamlessly manage and document the automation and control equipment of all leading suppliers.

Werum PAS-X MES ensures smooth exchange of information between your IT and production systems. Via digital control, you manage your processes paperlessly, use production data intelligently, and increase efficiency of production thanks to a higher degree of integration. The PAS-X interfaces comply with international industrial standards (OPC, XML, REST, etc.), while the functional assignment follows standards such as ANSI/ISA 95 and ANSI/ISA 88.

With the integrated IT and production systems, you benefit from production strategies such as Data Integrity by Design, lean production, Six Sigma, performance monitoring, and right-first-time.