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| PAS-X news 08 |
Werum‘s new regional offices
in Cary, NC (left), and
Pasadena, CA, provide
local customer support services.
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| Growing Market Share for Werum |
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New Regional Offices in California and North Carolina
Werum continues to grow in the U.S.A. and has opened two new regional offices in April 2008. Werum now also provides support to its customers from Cary, NC, and Pasadena, CA. Christian Fortunel, Vice President Consulting & Operations, will head the regional office in Cary.
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To the head of the regional office in Pasadena, Werum recently hired Marc Puich, Vice President MES Program Management. The U. S. headquarters of Werum America will remain in Parsippany, NJ. At the present time, Werum is actively recruiting highly-qualified personnel for all three of the company‘s US locations.
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The opening of the new offices reflects Werum‘s constant growth in the American pharma and biotech markets.
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Hartmut Krome, President of Werum America: ”The year 2007 has so far been the most successful business year for Werum America since it was founded in 2001. Compared to the previous year, sales increased by 40%.” In 2007 Werum signed global frame agreements with three more of the top-20 pharmaceutical companies, so Werum owns a significant market share of the top 20. “I would like to thank all these major companies for the trust and confidence in Werum and its product PAS-X. We will keep the speed and do it even better,” Mr. Krome adds.
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Independent analysts now rank Werum as the number-one MES provider for the pharmaceutical and biopharmaceutical industries.
The addresses of the new locations of Werum America are:
Regional Office in North Carolina
8000 Regency Parkway, Suite 505
Cary, NC 27518
Regional Office in California
790 E. Colorado Blvd., 9th Floor
Pasadena, CA 91101
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| PAS-ECMI: An SAP-Endorsed Business Solution by Werum |
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Werum and SAP have forged an SAP-Endorsed Business Solution partnership for the life science sector, where Werum enhances the SAP solution in the field of batch production.
SAP-Endorsed Business Solutions are complementary to current SAP capabilities, and are developed in accordance with SAP development guidelines to provide additional choices and flexibility for businesses running SAP software. SAP builds on Endorsed Business Solutions wherever software packages of selected partners help fill the “white spaces“ of the SAP Solution Map.
PAS-ECMI (Extended Compliant Manufacturing Integration), Werum’s certified SAP-Endorsed Business Solution Package contains three software modules that support central functions in pharmaceutical production: Weighing and Dispensing (ECMI-WD), Master Batch Records Management (ECMI-MBR), and Electronic Batch Recording (ECMI-EBR). Apart from a basic system configuration, this package comes configured with standard business processes, the required interface integration and all required documentation.
This collaboration between SAP and Werum provides best-value solutions targeted at life science batch manufacturers, who aim to cut operational costs, ensure compliance and achieve operational excellence.
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| Five at a Blow: Simultaneous PAS-X Rollout at Five Sites |
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One of the world’s largest biotech companies has successfully completed a further step of implementing Werum‘s PAS-X MES. In a final phase, the customer has – at the same time as introducing SAP – extended the existing PAS-X Weighing & Dispensing solution, which is utilized at five of the customer’s production sites, by adding further functionality, such as material tracking. Together with the parallel transition to SAP, the biotech company also accomplished a cross-system ERP-MES integrationof weighing & dispensing and warehouse management businessprocesses.
The technical integration platform that has been used is the SAP Exchange Infrastructure (SAP XI), through which PAS-X and SAP communicate and exchange XML-based information. Werum had built the interface as a conference room pilot and tested it with the project team extensively before it has gone live in a real production environment in a “big bang“ approach.
Three additional business processes have been enabled by the integration of the MES with SAP: process order execution with phase closure information feedback to SAP, optional batch determination in MES, and material tracking in MES.
The integrated PAS-X Weighing & Dispensing solution offers a range of functional extensions for materials and order management. Another new feature is the point-of-use verification, where centrally weighed containers are incorporated into the production process in a system-controlled and well documented manner.
Werum‘s MES solutions are operational since April 1st, 2008, at the customer’s plants on the East Coast, West Coast, and Puerto Rico. This MES rollout was one of the largest “big bang” projects in the MES IT space.
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| Global MES Master Agreement with Merck Serono |
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Werum and Merck Serono KGaA have closed a global agreement for the delivery of MES systems. According to the Global MES Master Agreement Merck Serono plans to introduce standardized MES solutions for both its pharmaceutical and biotechnological lines of production based on PAS-X.
To start with, Merck Serono has placed the order for two MES projects: Werum will deploy PAS-X PHARMA at the Darmstadt (Germany) pharmaceutical production site; simultaneously, Merck Serono will equip a new biotech factory to be built in Vevey (Switzerland) with PAS-X BIOTECH. Afterwards PAS-X will gradually be rolled out to further production sites around the world.
Uniform production business processes are expected to bring Merck Serono three major advantages: They will help to reduce the production risk, substantially shorten the time needed for documentation and significantly speed up the release of manufacturing documentation and reports.
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| MES Best Practices: S95 and S88 |
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Interview with Klaus Schreiner, Head of PAS-X Product Development
The use of MES has become a best practice in the pharmaceutical industry.
Mr. Schreiner, why would you agree with this statement?
The world’s largest pharmaceutical companies have recognized the huge potential of MES as an essential building block of their internal IT architecture and are implementing MES, for example to support operational excellence strategies. The pros and cons of MES are hardly debated anymore nowadays. Discussions are rather centered around functional aspects and the MES integration to other systems. In short: MES has become a widely accepted standard in production-related information systems of larger pharmaceutical companies. We are also noticing growing interest from generic drug manufacturers because the return on investment is attractive when using standardized and mature products like PAS-X.
Let’s have a closer look: Are there best practices for the integration of MES?
Yes, the ISA S95 and ISA S88 standards are relevant and binding for MES integration concepts. They provide guidelines for the assignment of tasks between the MES and the ERP level and between the MES and the equipment control level, where you find DCS or SCADA systems. These standards particularly prove their value in concrete project situations where it is no longer necessary to work out long-winded definitions before identifying the most appropriate assignment of functions to the different IT systems.
Best practices do not just cover functional aspects, but also present helpful approaches and methodologies to facilitate project work. We recommend that our customers first work with sandbox or pilot systems and thus test the MES suitability in the intended system environment and the interaction of interfaced systems under real conditions.
How does PAS-X map the requirements of S95 and S88?
The distribution of functions for the MES level-3 as suggested by S95 and S88 is in particular mapped by the standard interfaces provided to the ERP level-4 and the DCS/SCADA level-2 functions.
Werum has developed a best practice integration scenario for communication with level-2 components and defined an OPC-based standardized interface that fully implements the S88 requirements. Adapters for the market leading DCS systems, including ABB, Emerson, Honeywell, Siemens and Yokogawa, complete the integration scenario. Thanks to our orientation towards S88 we have managed to notably reduce integration efforts in our projects.
Werum has completely remodeled the MBR application for the upcoming product version V3. What are the most important functional novelties of this revised MBR module now?
The new MBR module offers a number of practical and handy functions that simplify and speed up the process for developing and maintaining recipes.
Users now have a broader range of options for graphically designing recipes. Additional description levels allow them to map the most complex manufacturing processes with the MBR application. Reusable functions and text blocks are made available in libraries; this is timesaving and convenient, especially as PAS-X enables referencing to library elements. This means that recipe changes can be entered centrally and, if desired, even incorporated into the productive MBRs.
For this development we again had our clients provide valuable input based on their daily experience with previous versions of the system.
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| Bayer HealthCare in Berkeley Introduces PAS-X Software |
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At its Berkeley location in California, Bayer HealthCare launches the implementation of Werum’s PAS-X system for its biotech manufacturing processes. In a first step, the Werum Manufacturing Execution System (MES) will be installed in media production.
Bayer intends to roll out the MES, which primarily focuses on Electronic Batch Recording (EBR), for running all its manufacturing processes by 2009.
The functional scope of the MES goes far beyond a mere EBR system. The MES will also include applications for Master Batch Record Management (MBR), Weighing & Dispensing (WD), Deviation Management, and Material Tracking. The MES will be integrated with other existing systems, including the SAP system, a distributed control system (DCS), a laboratory information and management system (LIMS), and a document management system (DMS).
Bayer’s Berkeley location manufactures the hemophilia medication Kogenate®, which is produced using genetic engineering techniques.
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| DCS Integration – Dedicated Interface for DeltaVTM |
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Werum has introduced its vendor independent PAS-X OPC framework to integrate its MES with DeltaVTM by Emerson.
Since all major control system vendors offer an OPC interface for their control systems, the principles and communication techniques used to communicate to DeltaVTM via
OPC are applicable to any control system supporting the OPC standard.
The OPC layer in PAS-X contains two generic interface programs, one for exchanging tag information via OPC-DA (bi-directional),
and receiving alarms and events (OPC-AE, read-only from the OPC-AE server). These programs are proven to communicate to any other compliant OPC server over an Ethernet network.
As an option, this module can communicate with DeltaV’s Campaign Manager using the DeltaVTM Campaign Manager control, an ActiveX® software library
shipped with DeltaVTM.
The first installation of Werum’s DCS integration interface with DeltaVTM has been finished in the course of a project at
Merck & Co.’s new vaccine manufacturing plant in Durham, NC, where Merck deploys PAS-X to manage its compliant production processes.
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Overall Architecture
of the System |
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| Werum and EnteGreat Announce Joint Training Program for PAS-X |
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Werum has designated EnteGreat, based in Birmingham (Alabama), as its exclusive PAS-X TRAINING partner for North America. Under the partnership agreement, EnteGreat personnel certified as PAS-X trainers will deliver standard PAS-X training classes at EnteGreat locations.
EnteGreat is a manufacturing consulting and systems integration company, serving life science as well as food, beverage and CPG manufacturing enterprises primarily within North America. EnteGreat‘s strategy focuses on combining best of breed technologies, such as MES PAS-X, with transformative change processes to drive sustainable business and operational improvements for its clients.
Over the past several years, Werum and EnteGreat have collaborated on manufacturing execution initiatives for a variety of life science enterprises. The training partnership is indicative of the expanding business relationship between Werum and EnteGreat.
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Werum worldwide
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New Regional Offices 
