PAS-X NEWS PAS-X V3 UPDATE AT ONE OF THE WORLDWIDE MOST IMPORTANT J&J SITES

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1 JOHNSON & JOHNSON, BELGIUM PAS-X V3 UPDATE AT ONE OF THE WORLDWIDE MOST IMPORTANT J&J SITES Plant in Geel, Belgium, updated to Werum s PAS-X V3.1.5 / Key role for manufacturing of important chemical APIs / EBR with mobile end devices The multinational pharmaceutical and consumer goods manufacturer Johnson & Johnson updated their site in Geel, Belgium, to PAS-X V The Geel site plays a key role for Johnson & Johnson: In this plant, the company manufactures important active pharmaceutical ingredients, for instance for cancer medication, that are then processed further in other facilities around the globe. CONTENTS JOHNSON & JOHNSON, BELGIUM 01 ACTAVIS, BULGARIA 01 Johnson & Johnson has already implemented Werum s PAS-X in some plants, says Anje Vermeiren, Senior Manager Manufacturing Systems of Johnson & Johnson. After operating the previous version for about two years, we have updated the PAS-X system in Geel in order to benefi t from the improved out-of-the-box product functionality such as enhanced Master Batch Record functions, easier ways of reviewing Electronic Batch Records and enriched handheld functionality. ACTAVIS, BULGARIA In Geel, PAS-X is in operation as fullblown MES in several areas of API manufacturing and the product warehouse. A total of about 300 employees uses the PAS-X system. NOVO NORDISK, BRAZIL 02 SPIMACO, SAUDI ARABIA 02 INTERVIEW WERUM AND KÖRBER MEDIPAK SYSTEMS 03 PAS-X FOR MID-SIZED PHARMA COMPANIES 04 INTERNATIONAL GENERICS MANUFACTURER ACTAVIS UPGRADES TO WERUM S LATEST PAS-X VERSION V3.1.6 Upgrade in main site in Dupnitsa, Bulgaria / Extended out-of-the-box functional scope supports more efficient control of processes / PAS-X rollout to other plants planned OCTAPHARMA, AUSTRIA 05 FRESENIUS KABI, SWEDEN 05 UNIGEN, JAPAN 06 ASTRAZENECA, CHINA 06 BAYER HEALTHCARE, ITALY 07 NOVARTIS PHARMA, IRELAND 07 INTERVIEW PAS-X V3.1.7 USABILITY 08 FDA COMPLIANCE EXPECTATIONS 09 PAS-X PACKAGING SOLUTION 10 PAS-X KPI SOLUTION 11 Actavis, the fast-growing generics manufacturer, upgrades to the latest PAS-X version V3.1.6 at their Bulgarian site in Dupnitsa. With an annual output of more than 6bn tablets, Dupnitsa is one of the largest manufacturing facilities of Actavis worldwide. After running the existing PAS-X MES for three years, the company decided to upgrade to PAS-X V This will enable them to better manage and control their comprehensive internal logistics and increase the effi ciency of the manufacturing processes decisive advantages on the highly competitive generics market. PAS-X V3.1.6 offers a signifi cant increase in functionality. This enriched toolset gives us the ability to do exactly what we want and eliminates any need for customization, says Brandur Hauksson, Validation Manager, Actavis. Actavis intends to roll out Werum s PAS-X to other sites around the globe. INTERVIEW PAS-X TRAINING 12

2 NOVO NORDISK, BRAZIL GO-LIVE OF NEWEST PAS-X VERSION IN THE CONTEXT OF NOVO NORDISK S LARGEST EVER IT INITIATIVE Combined ERP/MES rollout in the framework of PS@SAP / Excellent go-live support Novo Nordisk, the world market leader in diabetes care, implemented PAS-X V3.1.5 successfully at their Brazilian site in Montes Claros. With 18 production lines in fi ve process areas, including lines for formulation, fi lling, inspection, assembling and packaging insulin pens, and two lines for tablet packaging, Montes Claros is one of the company s largest sites. PAS-X was rolled out with SAP in the context of the global PS@SAP program, Novo Nordisk s largest ever IT initiative to install a globally standardized ERP/MES solution across all production sites. Montes Claros has been the fi fth site on the PAS-X rollout plan. Since PAS-X V3.1.5 covers all major functionalities out of the box, only minor customizations were made. Werum s support as we went live was excellent, for example putting people on site short-term and providing support whenever needed, says Roberto Soares Toledo, Novo Nordisk s project manager in Brazil. Since PAS-X is so fl exible, user-friendly, and intuitive, it s possible to begin with the basics and then build on these, learning to use PAS-X step by step. The next stage of the PS@SAP rollout is already underway, with a PAS-X installation at Novo Nordisk s site in Tianjin, China. SPIMACO, SAUDI ARABIA LEADING ARABIAN PHARMA COMPANY SPIMACO OPTS FOR PAS-X THE MARKET-LEADING PHARMA MES BY WERUM Full-blown MES implementation at main manufacturing plant in Qassim, Saudi Arabia / Market leadership, compliance and PAS-X Content Packages as decisive factors As one of the largest Arabian pharmaceutical manufacturing companies, SPIMA- CO has opted for PAS-X, the leading Manufacturing Execution System (MES) by Werum. The company will operate PAS-X as a full-blown MES at their main manufacturing plant in Qassim, Saudi Arabia, where they produce pharmaceutical products for the Middle East and also for North Africa. SPIMACO required an IT system for controlling and documenting their manufacturing processes. They were looking for a system that enjoys a high level of acceptance in the pharmaceutical industry and complies with all requirements by the national and international regulatory authorities. Another crucial factor for SPIMACO s decision was that in addition to the PAS-X software product, Werum also offers pre-confi gured PAS-X Content Packages including GMP-compliant templates. Especially the process libraries based on industry standards will tremendously reduce implementation time and efforts, says Moin Ul Haq, Business Application Manager, SPIMACO. PAS-X will help us to capture the real-time production activities and to reduce the batch review time by 40 %. PAS-X will be the second largest system in SPIMACO s IT landscape and it will be integrated with SAP, the core business system at SPIMACO. SPIMACO is expecting to go live with PAS-X in January

3 INTERVIEW WERUM AND KÖRBER MEDIPAK SYSTEMS IDEAL PARTNERS FOR INTEGRATED SOLUTIONS FOR THE PHARMA AND BIOTECH INDUSTRY The international technology group Körber acquired the shares of Werum IT Solutions, formerly Werum Software & Systems AG. Gerhard Breu (CEO Körber Medipak Systems) and Rüdiger Schlierenkämper (CEO Werum IT Solutions) speak about the motivation for the acquisition, benefits for the customers and future PAS-X developments. Gerhard Breu Rüdiger Schlierenkämper Why did Körber acquire the software company Werum? Breu: Because Medipak Systems and Werum are the optimal fit. Medipak Systems specializes in inspection and packaging solutions for pharmaceutical products. Software solutions are becoming increasingly important to Körber. Our goal is to become the strategic partner to the pharma industry. Schlierenkämper: As the leading provider of MES systems for pharmaceutical and biotechnological manufacturing, Werum s activities dovetail perfectly with the portfolio of Medipak Systems. We see Körber as ideal partner with whom we will be able to open up new perspectives in the pharma MES market of the future. What are the benefits for the customers? Schlierenkämper: With Dividella, Mediseal, Rondo, Seidenader and Werum five successful suppliers to the pharmaceutical industry are now united under the umbrella of Medipak Systems. In addition to enhancing Werum s MES business, we will jointly develop new and unique products for our customers in the international biotech and pharmaceutical industry. This means our customers are provided with integrated technologies and products, all from a single source. Schlierenkämper: We will use Körber s international presence and our experienced Werum employees to attract new customers and to serve our long-term customers even better wherever they are doing business. We are in the process of expanding Werum s global activities beyond our wellestablished presence in Europe, North America and parts of Asia. By the end of this year, a new Körber Medipak Systems site will be established in Brazil near Sao Paulo. Werum customers will benefit from this new branch: the local team also includes Werum experts who will be able to support our customers even better at short notice. The next focus of our internationalization strategy will be on Asia in particular extending our footprint in India. Will Werum solely focus on solutions for packaging processes in the future? Breu: No. Werum will offer IT solutions for improving the efficiency of all manufacturing-related processes. Under the roof of Medipak Systems, Werum will consequently continue to offer and further develop the existing range comprising process development, manufacturing processes and packaging. Werum will extend its position as the leading MES supplier for pharma and biotech companies. What will be the focus of the future PAS-X product development? Schlierenkämper: Usability will be a primary emphasis of the PAS-X product development. With our next PAS-X version we will make working with PAS-X more intuitive, improve communication between the operator and the system and optimize the system for use on mobile devices. We want to design innovative PAS-X solutions for the Smart Factory 4.0. It is our vision that PAS-X communicates with equipment on the shop floor and guides the operator through the process. Will Werum expand its international presence and activities? 3

4 SMART SOLUTIONS LEADING MID-SIZED PHARMA AND BIOTECH COMPANIES BENEFIT FROM PAS-X OUT OF THE BOX Complete MES functionality and implementation times of less than 12 months / Best-practice-based content packages including pre-configured business processes Medium-sized pharma and biotech companies face enormous challenges: They are required to improve effi ciency and quality, to reduce costs and cycle times and to meet regulatory requirements. This situation is aggravated by the increasing pressure to consolidate, fi xed budgets and the cutthroat competition in these industries. out-of-the-box MES package including the standard software product, pre-confi gured content and comprehensive services all specifi cally tailored to the pharmaceutical industry. Customization can almost entirely be omitted resulting in implementation times of less than 12 months. The system is easily scalable enabling customers to start with selected functions as an introduction to MES, and to later extend the system to cover other functions or process areas. Content and service packages to facilitate implementation As the market leader, we provide a unique offering: our out-of-the-box PAS-X MES with complete and scalable functionality that is operational in less than 12 months. Lars Hornung, Senior Head of Sales / New Business, Werum IT Solutions GmbH PAS-X Content Packages which include pre-confi gured workfl ows and business processes based on the pharma and biotech industries best practices ensure a comparably fast implementation. In this way, customers do not have to start from scratch when confi guring PAS-X. Out-of-the-box MES for fast implementation Werum s PAS-X MES provides optimal support in meeting these challenges. PAS-X is not only suitable for the largest global pharma organizations, it also fulfi lls the needs of medium-sized pharma and biotech companies: Werum delivers a complete Complete and scalable functionality PAS-X is a stable and mature industryspecifi c software product providing all MES functionalities required by medium-sized pharma and biotech companies. Functions include Weighing & Dispensing, MBR, EBR and Equipment Management, to name just a few. Instead, they can use predefi ned templates and libraries specifi cally designed for the production processes of the pharma and biotech industries. Werum also provides consulting service packages to support customers in using these templates and to facilitate a smooth implementation and go-live. Wherever the customer s location is, Werum experts are available. PAS-X MES FOR GROWING MID-SIZED PHARMA AND BIOTECH COMPANIES SPIMACO wanted to control its production process activities by using a tool which is being well accepted in the pharmaceutical industries and fulfills all regulatory requirements. PAS-X will help us to capture the real time production activities and to reduce the batch review time by 40 %. Especially the process libraries based on industry standards will tremendously reduce implementation time and efforts. Moin Ul Haq, Business Application Manager, SPIMACO We currently upgrade to PAS-X V at our main manufacturing plant in Dupnitsa, Bulgaria. PAS-X V 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. Brandur Hauksson, Validation Manager, Actavis Our main objective is to renew the software architecture on the production level by using an out-of-the-box product. We have chosen PAS-X in order to benefit from the extensive standard functions and the best-practice expertise Werum offers in the pharmaceutical industry. PAS-X will be the leading system integrating SAP and LIMS. Herman Geudens, Plant Manager, Sanico N. V.

5 OCTAPHARMA, AUSTRIA OCTAPHARMA ADDS TRACK & TRACE SOLUTION TO WERUM S PAS-X MES Go-live at production site in Vienna / Processing of Chinese serialization numbers / Expansion to further packaging lines and countries human cell-lines. Patients in over 100 countries are treated with products in the areas of haematology, immunotherapy and critical care. Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico. Octapharma employs strict in-process quality control systems to ensure traceability, providing the complete documentation of the origin of all plasma donations, their processing and distribution to countries worldwide. The company requires a flexible and stringently validated system for marking, identifying and tracking their products. Octapharma, one of the largest independent manufacturers of human protein products worldwide, has added the PAS-X Track & Trace Serialization Aggregation solution to Werum s PAS-X at their production site in Vienna. Octapharma has been committed to patient care and medical innovation for over 30 years. Its core business is the development, production and sale of human proteins from human plasma and In a first step, PAS-X Track & Trace will be operated in the packaging area for the Chinese market. The serialization data provided by the Chinese authorities are loaded and the used data are reported back. PAS-X Track & Trace is interfaced to the existing PAS-X and exchanges order and stock data with the MES. It is intended to install Werum s PAS-X Track & Trace at further packaging lines for different target countries in the Vienna site. FRESENIUS KABI, SWEDEN FRESENIUS KABI INTRODUCES WERUM S PAS-X V3 AT THEIR SWEDISH PRODUCTION SITES Incremental rollout in Sweden / Compliance, quality and cost savings Fresenius Kabi is a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. They will roll out Werum s PAS-X in the latest V3.1.6 version at the Brunna and Uppsala sites in Sweden. Fresenius Kabi already operates PAS-X at other sites and has just entered into a framework agreement with Werum. In Sweden, the company produces injectable emulsions for clinical nutrition. At first, PAS-X will be implemented for weighing and filling operations. In a second step, PAS-X will be rolled out to further operations. PAS-X fully integrates the SAP ERP through a central interface. By introducing PAS-X, we will be able to ensure the best possible compliance and quality standards in our manufacturing, says Cecilia Sjöstedt, plant manager at Fresenius Kabi in Uppsala. Through the accelerated electronic batch execution and documentation, we expect more efficient release processes which also will enable cost savings. Fresenius Kabi is planning more PAS-X V3 implementations at their sites all around the world. 5

6 UNIGEN, JAPAN MES FOR BIOPHARMACEUTICAL PRODUCTION IMPLEMENTED IN ONLY FOUR MONTHS World s largest biotech plant for contract manufacturing of recombinant influenza vaccines set up / PAS-X standard software product, fast-track implementation and MBR modeling accelerate MES deployment The Japanese biotech company UNIGEN Inc. has taken Werum s PAS-X MES into operation within a record time of only four months after completing the Fit Phase. The short implementation time was possible because the company relied on a standard solution. PAS-X is operational with all functionalities out of the box. UNI- GEN implemented PAS-X using Werum s four-phased fast-track implementation methodology: Ready, Fit, Build and Run. Part of the project was the fl exible and easy-to-handle PAS-X content and library based MBR modeling. At the greenfi eld site in Gifu, Japan, the joint venture of the Japanese pharmaceutical company UMN Pharma and the heavy equipment manufacturer IHI Corporation set up one of the largest plants for production of recombinant infl uenza vaccines and contract manufacturing of biopharmaceutical products. UNIGEN uses an innovative and complex biopharmaceutical manufacturing process called Baculovirus Expression Vector System (BEVS). For this process, UNIGEN required a standardized production management software, which is able to meet the high quality and compliance standards in accordance with the Japanese zero-error tolerance. PAS-X was delivered with the entire user interface in CST and Werum project managers at project acceptance Japanese. Werum carried out his project in close cooperation with their Japanese partner CST Chiyoda System Technologies Corporation. ASTRAZENECA, CHINA FURTHER PAS-X GO-LIVE IN THE CONTEXT OF ASTRAZENECA S OPERATIONAL EXCELLENCE STRATEGY Standardized weighing processes and compliance at the new Chinese facility in Taizhou, Jiangsu province / PAS-X user interface localized in Chinese PAS-X Weighing & Dispensing went successfully live at AstraZeneca s new facility in Taizhou in China s Jiangsu province. Here the world s fi fth-largest pharmaceutical manufacturer produces oral solid medicines for the growing Chinese market. For the green-fi eld site, AstraZeneca required a software product that offers standardized processes and compliance to the weighing and dispensing operations. The current project is part of the global strategy that AstraZeneca follows to achieve operational excellence in manufacturing. The rollout is based on the PAS-X standard software product. PAS-X Weighing & Dispensing, whose user interface is localized in Chinese, integrates existing weighing systems seamlessly into the manufacturing process. PAS-X is integrated into AstraZeneca s decentralized SAP ERP system. Werum s PAS-X Weighing & Dispensing is already in operation at other sites of Astra Zeneca in China, India, Sweden and the USA. The decisive factors for using this product were the extensive range of functions offered by PAS-X MES, the standardized SAP integration features, and Werum s global service network. 6

7 BAYER HEALTHCARE, ITALY BHC INTRODUCES WERUM S PAS-X TOGETHER WITH SAP AT ANOTHER ITALIAN SITE PAS-X go-live at the Segrate production site in Italy / Basis for standardized processes in all Italian plants Bayer HealthCare, the international pharmaceuticals group, successfully implemented the BHC standard MES system based on PAS-X V3 in their Segrate plant. The Italian site specializes in the production and packaging of creams, ointments and gels and serves as supply center for about 120 countries worldwide. In the context of modernizing the IT landscape of the former Schering AG plant, PAS-X was rolled out together with SAP. The PAS-X MES now controls the allocation of all input materials in the required quantities. With this recent go-live, the two Italian BHC plants in Segrate and Garbagnate are now running the PAS-X MES. For Bayer HealthCare, this implementation forms the basis for standardized processes across all Italian sites. NOVARTIS PHARMA, IRELAND NOVARTIS MIGRATES ANOTHER SITE TO THE LATEST V3 PAS-X VERSION BY WERUM Accelerated batch release processes as well as technological and functional improvements / Pilot project for the global Novartis Pharma PAS-X SAP MII interface Novartis Pharma successfully migrated the Irish production site in Ringaskiddy near Cork to the latest PAS-X V3 version by Werum. This division of Novartis produces important active pharmaceutical ingredients for the production of Novartis patent-protected prescription drugs. After three years of managing production processes with PAS-X, Ringaskiddy migrated to the latest PAS-X version. The technological and functional improvements of the new V3 version allow the site to speed up operation processes and increase efficiency. PAS-X is run as a full-blown MES in the whole plant. Supported by PAS-X, we can significantly expedite batch release processes and reliable warehouse management is now much easier to ensure, says Alan Daly, Automation Support, Novartis Pharma. It was a pleasure to work with Werum s highly professional team and we look forward to collaborating again on future projects. At the Cork site, Novartis Pharma for the first time implemented PAS-X with a standardized interface to SAP MII. This interface will become an integral element of all PAS-X systems at Novartis Pharma. 7

8 INTERVIEW PAS-X V3.1.7 USABILITY: A WHOLE NEW LEVEL OF USER EXPERIENCE Statement by Monica J. Cahilly, President, Green Mountain Quality Assurance Interview with Robert Welter (Head of PAS-X Product Management, Werum IT Solutions) and Svenja Fischer (Usability Expert, Werum IT Solutions) about the role of usability for the further development of PAS-X and the usability improvements of the upcoming PAS-X V3.1.7 version How important is usability in the context of the further development of PAS-X? Welter: Pharmaceutical companies have to make their production more effi cient and agile. To meet these requirements, an MES system is needed that is not only Robert Welter convincing in terms of functionality but also in terms of usability and allows easy and effi cient system operation without a long training period. Besides developing new functions, it is most important in PAS-X development to ensure a high level of usability. How is the topic usability established at Werum? Fischer: We hired specialists with expertise in the fi eld of usability and design of user interfaces. In this way, we can combine the expertise in usability with the technical know-how of the software engineers that are well-experienced with Svenja Fischer PAS-X. We are also well-acquainted with empirical standards and norms and with most recent fi ndings in psychology of perception. We also consult a design agency to further optimize human-machine interaction. By leveraging our internal employee feedback system, all Werum staff members can contribute their own ideas on PAS-X usability based on their project experience. How are PAS-X users involved in the improvement process? Fischer: We interview end users and watch them as they operate PAS-X. In addition to this, we invite users from all levels to our workshops: this includes the operator from the shop fl oor as well as the shop fl oor supervisor, the MBR designer and the master data administrator. In close collaboration with the member companies of the PFU the PAS-X For Us User Forum and other interested customers, we develop novel concepts for future versions of PAS-X. We also involve our customers when we implement the ideas. They can participate in the agile software development process. Thus, we receive an early feedback by the users and enhance the quality of PAS-X. Dialog with optimized touch operability What do you actually mean by software usability? Fischer: Usability means that a computer program supports the task of the user and realizes the principles of software ergonomics. The objective is to avoid errors in operation and to optimally support users in their actual tasks by designing a graphical user interface the so-called GUI that can be understood intuitively. When designing the GUI, the tasks of the end user, empirical fi ndings and guidelines as well as the technical feasibility are considered. Dialog for operators 8

9 What are the specific improvements in PAS-X usability? Fischer: With the upcoming PAS-X V3.1.7 version, the dialog for electronic batch recording was given a new design to optimally support users on the shop floor in performing their tasks. Despite the complete functional scope of PAS-X, we are able to display the information in a way that allows the operator to work intuitively and efficiently. We want operators to focus on the essential aspects of their working process while still being able to find additional information at any time and in a direct way. We also optimized the touch operability of the execution dialog. The buttons are now placed in a better position with an improved design and the font size can be changed. This is particularly relevant for mobile devices and Asian languages, such as Chinese and Japanese. Are there further examples for the improved usability? Welter: Yes, PAS-X has device-optimized dialogs. For this purpose, we had a look at the devices the operators use and then we provided improved usability. Depending on the device, users are displayed a dialog that has the optimal size and can be operated easily. Our new KPI Solution also comes with device-optimized dialogs. They are optimized for large screens, as for example used at packaging lines, as well as for tablets for the supervisor. The GUI has a well-structured and colorcoded design that draws the operator s attention to the essential aspects. Monitors on the shop floor display all important Key Performance Indicators in real time so that operators and supervisors can view the status of their line at any time. And yet another improvement: Due to the feedback by end users from the shop floor, we optimized particular automatic processes to improve the user experience on the shop floor. COMPLIANCE FDA COMPLIANCE EXPECTATIONS FOR EBR-MBR VALIDATION Statement by Monica J. Cahilly, President, Green Mountain Quality Assurance US and E U regulatory observations highlight the importance of adequate controls to document data integrity that is, controls must ensure that data used to make decisions that may affect patient safety is accurate, complete, consistent, and reliable. These expectations include that data integrity control strategies are risk-based, i. e., commensurate with the potential impact of the regulated process on patient safety and product quality, and that these include measures to prevent and detect data integrity issues. Implementation of an MES-controlled manufacturing process, using EBR, promises to reduce data integrity risks as well as improve the business efficiencies and effectiveness associated with the critical processes of lot release and batch record review when compared to a manually con- trolled manufacturing process documented on paper batch records. Realizing this promise requires that the MES-EBR system be properly implemented and validated to ensure mastery of these complex workflows by the technology. For example, thorough and documented control strategies would be expected to preventatively mitigate any risks posed by the MBR design, functionality, and performance. These steps may include documented verification of the accuracy and completeness of the MBR master data entries and any calculation algorithms against predefined and validated process specifications. Monica J. Cahilly Simple, efficient, and effective automated manufacturing and batch record review processes are realized when the technology, and those implementing it, absorb the complexity of these workflows through sophisticated design and control. In the words of Steven Jobs: It takes a lot of hard work to make something simple, to truly understand the underlying challenges and come up with elegant solutions. The shared talents, dedication, and hard work of Werum and the PAS-X User Community hold the key to these elegant solutions for PAS-X. 9

10 PACKAGING THE PAS-X PACKAGING SOLUTION Performance, compliance and serialization are the key challenges of today s pharma and biotech packaging operations. Shop floor operators face three major tasks: Operate the line and ensure right-fi rst-time operation Optimize performance of the packaging process including changeover Manage the serialization and aggregation process PAS-X: Standard system for EBR, OEE and Track & Trace Werum supports pharma and biotech companies with the PAS-X Packaging Solution a combination of software, content and services relevant for packaging operations. The solution offers functions that include EBR, Overall Equipment Effectiveness (OEE) and Track & Trace Serialization Aggregation with a single user interface. This way, both operators and administrators need to use only one easy-to-use system. As the central Level 3 application, the PAS-X Packaging Solution integrates the ERP and the Central Serialization Repository with the shop fl oor packaging equipment and line controllers. Faster creation and maintenance of packaging MBRs Packaging processes always follow the same workfl ow and differ only in terms of product specifi c characteristics. All common parameters are summarized in generic Master Batch Records (GMBRs). Thus, the number of recipes can be reduced from hundreds of MBRs to only a few GMBRs. A faster creation and easier maintenance of packaging MBRs is additionally ensured by predefi ned, packagingspecifi c Process Libraries Content Packages. Together with a Werum consultant the templates will be confi gured to suit the customer s specifi c business processes. Efficiency gains and standardization through integration with PAS-X To integrate the PAS-X Packaging Solution with an existing PAS-X MES is the easiest and most benefi cial way for enhanced effi ciency. However, it is also possible to fi rst implement the PAS-X Packaging Solution and later expand the system into a full-blown PAS-X MES. The benefi ts: All functionalities are provided by the same standard system, only one user interface for the shop fl oor operators, and a seamless data exchange. LEVEL 4 ERP System Central Repository PAS-X is scalable. Customers can start with a small solution on the shop fl oor level (with equipment from any supplier) and extend it on a step-by-step basis up to a functionally complete, full-scope PAS-X MES system. In cooperation with Seidenader all architecture levels come from a single source. LEVEL 0-2 LEVEL 3 Line Controller SAP Certifi ed Integration with SAP Applications Packaging Solution MES Track & Trace Solution, KPI Solution Manual Packaging 10

11 MANUFACTURING INTELLIGENCE THE PAS-X KPI SOLUTION: SHOP FLOOR PERFORMANCE BOOSTER For efficient pharmaceutical manufacturing it is essential both for operators and supervisors on the shop floor and for production site managers to constantly monitor the operating data. Thus, all stakeholders can use the key performance data (KPI) from the production and packaging lines to optimize their processes or equipment. Werum s PAS-X KPI Solution provides powerful functions for ensuring operational excellence and lean manufacturing by combining PAS-X data and equipment data for performance management. On the shop floor, the PAS-X KPI Solution automatically acquires process data related to Overall Equipment Effectiveness (OEE) in real time. The results are visualized on different monitors and can be understood easily to aid decisions. Operators and supervisors can view the current status of the packaging lines and their production targets at any time. If data is not provided by the equipment, the PAS-X KPI Solution also allows operators and supervisors to manually enter the causes of interruptions, such as setup times, pausing times or maintenance. Production site managers benefit from standard reports allowing the analysis of aggregated data with drill-down functions for root cause analysis. For example, the OEEs for the same product on different equipment can be compared easily. The gapless recording of process data in the system facilitates continuous improvements in terms of efficiency, productivity and profitability. WHY PAS-X KPI SOLUTION KEY BENEFITS Live visualization of performance status on the shop floor Availability of key figures to aid decisions and optimize processes and equipment GxP-compliant Seamless integration with PAS-X MES modules Management Increased profitability software-aided decision making to facilitate improvement processes Supervisor Achieving production targets knowing that performance falls behind before problems arise Operator Increased transparency live monitoring of individual production performance and status Administration Ease of configuration all functions and data are available within a single system 11

12 INTERVIEW PAS-X TRAINING SERVICES: DEVELOPING SKILLED USERS WHILE KEEPING YOUR TEAM FOCUSED In this interview, Jörn Sawinski (Manager Training & Consultant, Werum IT Solutions) explains how Werum s training concepts, out-of-the-box training modules and video tutorials support the customer in an optimal way How does Werum support customers during PAS-X implementation? Sawinski: To ensure the success of a PAS-X project a comprehensive, elaborated training concept is of signifi cant importance. In a workshop, we analyze the specifi c training requirements in cooperation with our customers. It is important Jörn Sawinski to defi ne who requires which training and when the course is to be held in the very beginning. This approach enables a smooth, successful implementation and a skilled workforce prepared for go-live. How is the training concept put into practice? Sawinski: There are two options: We can either train selected key users who are then responsible for the training of all other users within their company. Or we can provide PAS-X training courses for all users. The latter approach is much more benefi cial for our customers because we relieve their key users in terms of workload. Additionally we guarantee the technical competence and high quality of the training courses. How are the PAS-X training courses structured? Sawinski: The PAS-X training courses are composed of standardized modules out of the box. These modules can be selected and organized fl exibly to cover all PAS-X functionalities for our customer s specifi c processes, such as chemical or biopharmaceutical API manufacturing. Based on reallife production processes in a virtual factory, our customers learn how to operate PAS-X and how they can optimize their processes and design them to be more effi cient with our software. There are three training tracks covering PAS-X operation, PAS-X administration and customer-specifi c topics. Where do the courses take place? Sawinski: We conduct the training courses in our modern training rooms at our headquarters in Lüneburg, Germany, at one of our worldwide locations or locally at our customers plants. You can download the PAS-X training program with all upcoming courses and dates at com. Are there any other novelties in the PAS-X Training Center? Sawinski: We are currently creating video tutorials for the PAS-X basic training course and for the new features of the PAS-X V3.1.6 version. The videos demonstrate how particular processes work and how the features are to be used. We will provide these tutorials in addition to our training courses. The participants can purchase the video tutorials to recall and permanently memorize the learned contents. This way, they have the opportunity to continuously repeat what they have learned and to signifi cantly improve the quality of the learning process. PAS-X OPERATION PAS-X ADMINISTRATION CUSTOMER-SPECIFIC TOPICS PAS-X Training Tracks Business functions, three levels (Basic, Professional, Enhanced) System administration Printing and reporting PCS administration Individual program for companies Operators Supervisors Key users Quality controllers Project managers Key users System administrators Operators Supervisors Key users Quality controllers Project managers IMPRINT: Werum IT Solutions GmbH Wulf-Werum-Str Lüneburg Germany Tel Fax info@werum.com