MES Software accelerates MBR and EBR handling.

Press Release Summary:

Intended for pharmaceutical and biotechnological production, PAS-X v3.1.6 offers extended control of storage conditions and automation of basic functions, optimizing both production security and efficiency in creating Master Batch Records or executing Electronic Batch Recordings. Alarm and event handling ensures optimized shop floor integration and guarantees continuous processes as well as smooth information flow between PAS-X and SCADA, DCS, and Historian systems.

Original Press Release:

New PAS-X Version V3.1.6 Stands for Simplicity and Efficiency

Werum further improved its best-in-class PAS-X MES / new technological features for accelerated MBR and EBR handling / all customers profit from innovations

Lueneburg, Germany, - In cooperation with the PAS-X User Community, Werum further improved the leading Manufacturing Execution System (MES) for pharmaceutical and biotechnological production. "We integrated new features and improved the usability, making working with PAS-X even easier and more efficient", says Robert Welter, Head of PAS-X Product Management, Werum IT Solutions GmbH. "PAS-X is a functionally complete and scalable MES out of the box, which widely automates actions that previously had to be performed manually."

Accelerated MBR creation
The newest PAS-X version V3.1.6 provides many new technological features. The extended control of storage conditions and the automation of basic functions improve both production security and efficiency in creating Master Batch Records (MBRs) or executing Electronic Batch Recordings (EBRs). MBR creation is further simplified by the "External Parameters" feature based on generic Master Batch Records (GMBRs).

"Our customers face the challenge of managing a large number of packaging MBRs while also being required to quickly react to changes, e.g. in packaging design. These changes can be quite complex today", says Robert Welter. "The new PAS-X feature offers the possibility of making changes in the ERP and directly creating an executable EBR. Thus, the creation of individual product-specific MBRs becomes obsolete. In this way, we enable our customers to considerably reduce the number of packaging MBRs and really accelerate MBR creation."

Efficient EBR execution and release
The new alarm & event handling ensures an even better shop floor integration and thus guarantees continuous processes as well as a smooth information flow between PAS-X and the SCADA, DCS and Historian systems. Via interface, PAS-X directly retrieves the exceptions from Level 2 and allows the seamless assessment of all exceptions. This improvement enables QM personnel to go for a full "Review by Exception" (including Level 2 alarm & events) and allows the accelerated release of Batch Record Reports (BRRs).

The release process can be even further accelerated by the "Auto-Closure of BRR" feature. It automatically closes the BRR if there are no exceptions. As a result, QM personnel do no longer have to check batches without any exceptions and critical parameters so that a manual release is not required anymore.

Upgrades: Customers benefit from PAS-X innovations
"All our customers can benefit from continuous PAS-X innovations and improvements. New functions are provided through upgrades without compromising the stability of a running system. This is ensured by our mature upgrade procedures", says Robert Welter. "For a successful introduction of PAS-X, we also offer support and consulting services as well as PAS-X Content Packages. Along with the innovative features of the latest PAS-X version V3.1.6, our customers can thus achieve a high return on investment."

Long-time customers, such as the fast-growing generics manufacturer Actavis, have already ordered upgrades to the newest PAS-X version and are enthusiastic about all the benefits: "We currently upgrade to PAS-X V3.1.6 at our main manufacturing plant in Dupnitsa, Bulgaria", says Brandur Hauksson, Validation Manager, Actavis. "PAS-X V3.1.6 offers a significant increase in functionality. This enriched toolset gives us the ability to do exactly what we want and eliminates any need for customization."

About Werum IT Solutions
Werum IT Solutions is the internationally leading supplier of Manufacturing Execution Systems (MES) for the pharmaceutical and biopharmaceutical industries. Its PAS-X software product is used by 17 of the world's top 30 pharmaceutical and biotech companies in more than 700 installations. Founded in 1969, the IT company employs more than 400 people at its headquarters in Lueneburg, Germany, and at nine other locations in Germany, France, Switzerland, the United States, Japan, and Singapore. For more information take a look at our website

Dirk Ebbecke
Director Corporate Communications
Werum IT Solutions GmbH
Wulf-Werum-Str. 3
21337 Lueneburg, Germany
Tel. +49 4131 8900-689
Fax +49 4131 8900-20

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