Merck MES Upgrade to Werum s PAS-X V3 gone live at one of its largest Plants

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1 Merck MES Upgrade to Werum s V3 gone live at one of its largest Plants Go-Live at plant in West Point, PA / Additional rollouts in the U.S. and China are on the way As part of its global MES rollout program, Merck Sharp & Dohme Corp., a subsidiary of the global healthcare company Merck, has successfully launched its standard MES system at the production site in West Point, PA. West Point is one of Merck s largest pharmaceutical and vaccine manufacturing plants producing a variety of products helping the world to be well. Continued on page 3 CONTENTS Merck Sharp & Dohme produces a variety of vaccines. Merck: Upgrade at one of its largest Plants p. 1 : Ready to Go Interview on strategy p. 1 Werum / OSIsoft partnership p. 2 Novartis: Suffern Site celebrates 10 years of MES p. 3 Out of the Box p. 4 Novo Nordisk: becomes central Manufacturing IT Platform p. 6 CSL: Go-Live in Melbourne p. 6 Merck Serono: On the Way to an Integrated Biopharmaceutical e-plant p. 7 Novartis: Go-Live of Process Development p. 7 Training Center: Interview on new training concept p. 8 : Ready to Go Interview on the Product Strategy with Marc Puich, Senior Vice President Sales and Program Management, Werum America Inc. What requirements does the pharmaceutical and biotech industry place on software in a production environment? Puich: Pharmaceutical and biotech companies expect a software product that covers all needed functionalities and is focused on the specific requirements of the industry. It should be implemented at the lowest possible costs within a short project timeline, and drive efficiencies that will result in a clear Return on Investment (ROI). But most importantly, the software must enhance operational quality and ensure compliance. Continued on page 2

2 ... Ready to Go.... Methodology Ready to Go in the U.S.... : Ready to Go Interview with Marc Puich Continued from page 1 Marc Puich, Continued from page 1 Senior Vice President Sales To what degree does meet the market expectations? and Program Management, Werum Software & Systems America Inc. Puich: We now supply a purpose-built, pre-configured package that includes software, content, services and training from a single supplier. Together with the PFU, the User Community, we have developed into a standard software product that provides all major functionalities required by the pharmaceutical and biotech industry Out of the Box. We believe that Werum is unique and on the leading edge by including predefined content targeted to our customer s processes together with the actual software. And it all can be supported with matched services. As the market leader, with we provide a mature product which is stable, offers high performance and enables fast implementation. Can you describe what fast implementation of means? Puich: Before the project in the Ready Phase we offer consulting services to ensure process understanding and the organizational readiness of our customers. This includes blueprinting, business case creation, and implementation and rollout planning. The actual implementation is then carried out in two phases: In the Fit Evidence Phase, our product is configured on-site to the business processes and production recipes of the customer. This phase also includes consulting and training, and by the end of this stage, the customer is, in theory, ready for operational use of the standard system. In the subsequent Build Phase, the product is configured or enhanced (for example, with interfaces), and it is implemented and qualified at the customer s plant. In parallel to this configuration, the sys- OSIsoft PI to be integrated into Werum s Werum customers can use key PI functionalities from within the system Werum Software & Systems will completely integrate OSIsoft s PI Plant Information Management System in its Manufacturing IT Business Platform. This way, customers can, in the future, benefit from key functionalities for the management of real-time data and events presented by OSIsoft PI. Customers who already work with OSIsoft PI can purchase a OSIsoft PI adaptor from Werum, through which they can seamlessly access the application from within the system. We are excited to announce the intensified cooperation with OSIsoft, says Robert Welter, Head of Department for Product Management at Werum Software & Systems. The planned integration of the industry-leading OSIsoft tem can be prepared for operational use through parameterization of the master data and creation of the final MBRs. At that point, the system can go live. Once the system is operational, we support our customers in the Run Phase with our global Service Desk Team and with maintenance agreements that ensure the protection of the investment with upgrade guarantees. Please tell us more about the content you mentioned. Puich: When setting up the system, the customer no longer needs to start with an empty application, but can instead utilize many pre-packaged modules developed by Werum. The content packages, with their GMP-compliant templates, can help ensure the correct setup of the system and speed up the overall project timeline. It also saves our customers considerable resource time in the typical trial and error process of learning a new software system and electronic approach to manufacturing. Our offering includes the User Rights and Roles Content Package for configuring user rights, the MBR Design Elements Packages for faster creation of electronic recipes from scratch and the Qualification Package that supports creation of project-specific labels and reports. The content packages are based on the best practices of our customers and driven by the User Community PFU. PI System into our software is another building block that makes a comprehensive standard product with all functionalities provided out of the box. With it, we can offer our customers a solution for fast implementation from a single source that results in improved total cost of ownership. Merck MES Upgrade to Werum s V3 gone live at one of its largest Plants The Merck MES system is based on Version 3, the newest offering of Werum s Manufacturing IT Business Platform. is a software solution that provides an extremely high level of standard functionality for the pharmaceutical sector Out of the Box. We re very satisfied with the recent deployment of MES at West Point, said George Llado, Merck s Vice President, Merck Manufacturing Division IT. On December 18th, 2012 the Novartis site in Suffern, north of New York, celebrated the 10th anniversary of its MES implementation and Go-Live. At this occasion the company hosted an all-day event with entertainment for the operators. It was a good opportunity to introduce version and to receive valuable feedback from operators proudly using Werum s system every day. Novartis Pharma has been one of Werum s first international MES key accounts. Since the V1 implementation at Novartis Suffern ten years ago became the Novartis MES standard system and is being used today in about 30 sites around the globe. In the context of its worldwide migration strategy, Novartis Pharma is planning to install the latest version at its Suffern site. Werum delivered the package on-time and within budget, providing exceptional support post go-live. MES is a mission critical productivity platform for the Company. Having a trusted supplier in Werum working very closely with our business and IT teams was essential to project success. The pharmaceutical company is running an MES program around the globe through 2015 as part of its rollout plan. Novartis Suffern celebrates 10 years of MES Already in the implementation phase: the Merck (known as MSD outside the United States and Canada) plants in Wilson, North Carolina, USA, and Hangzhou, China. Some impressive numbers about 10 years MES in Suffern 13,431 Total Master Batch Records 391 Active users 41,428 Orders 302 Workrooms 79 Scales 1,921 Setup parts 9,307,351 Interface messages between MES and ERP 99.98% System uptime, downtime mainly caused by database locks 2 3

3 ... Ready to Go Out of the Box... MBR Design Elements Package Process Development Process Development simplifies and speeds up the modeling of manufacturing processes for pre-clinical and clinical production. It offers a high degree of flexibility in early-stage batch recording and supports Design of Experiments (DoE) features to identify Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) to enable Quality by Design (QbD). Process Development improves process visibility, data analysis and information transfer across all stages. It covers process development in all areas of the pharmaceutical industry, including scale-up. The Design Elements are predefined basic operations for the fast creation of MBRs for pharmaceutical processes and show how these processes like IPC testing, granulation or reconciliation are typically modeled in. They are part of specific libraries available for various manufacturing types, such as solids and liquids. In addition, Universal Elements are also available which cover general processes. Packaging will also be part of the offering. The MBR Design Elements help to assure higher quality MBR design in the configured system. They come pre-tested by Werum, focus on the most efficient use of functionality, and are designed to operate together as a process moves through the plant. The Design Elements are based on the best practices of the industry and directed by the PFU, the User Community. They also act as a foundation to harmonize and standardize processes within or between different plants. Rights and Roles Package The User Rights and Roles Content Package is available for rapid configuration of user rights based on global profiles targeted to GMP compliance and pharmaceutical manufacturing. The 40 included user profiles, with predefined rights, are designed for defined roles in a GMP organization. In line with our project experiences, the descriptive names of the profiles make it clear which user these roles are targeted to. The User Rights and Roles Content Package considerably simplifies the configuration and maintenance of s highly flexible user rights capability. Based on the clear and well-structured documentation, system administrators and project team members can save up to 95 percent of the time usually required for the initial configuration of rights. The resulting testing effort is also reduced to a minimum. Track & Trace Serialization Aggregation Werum has developed a Track & Trace solution for the pharmaceutical industry to comply with anti-counterfeiting requirements for medical drugs. Track & Trace provides serialization and aggregation functionality for packaging processes and integrates the ERP and the Global Repository with the shop floor packaging equipment and line controllers. The package delivers a rich product-based functionality Out of the Box and allows analyzing the Overall Equipment Effectiveness (OEE) of packaging processes. By supporting different legal requirements Track & Trace offers more drug safety worldwide. 4 5

4 ... Ready to Go Worldwide... Werum s becomes Novo Nordisk s central Manufacturing IT Platform for different Applications at various Sites Go-Live of newest version of Novo Nordisk s MES Standard System at four major plants in Denmark, France and the U.S. / Harmonization of production processes and transparency across sites The global healthcare company Novo Nordisk successfully rolled out the newest version of its MES Standard System at production sites in Chartres (France), Hillerød and Kalundborg (Denmark) and in Clayton (North Carolina, USA). All four batch line plants run with the same consolidated MES Standard System using Werum s worldwide leading Manufacturing IT Business Platform. With this new standard platform, Novo Nordisk harmonizes its production processes and achieves greater transparency across all sites. At the new plant in Kalundborg, Werum s controls the filling of biopharmaceuticals. In Chartes, supports the filling of insulin, whereas in Hillerød und Clayton it supports the packaging and assembly of insulin penfills. The coordinated Go-Lives are part of Novo Nordisk s Program, which started in This worldwide IT initiative is designed to shorten production lead times and reduce production costs. The program will also implement cross-plant standardization, improvements to production processes and optimized procedures for quality assurance. Novo Nordisk Production of Novo Nordisk s insulin pens in Hillerød, Denmark. With on the Way to an Integrated Biopharmaceutical e-plant Go-Live of Werum s at Merck Serono in Vevey, Switzerland / Efficient Data Flows from Process Development to Commercial Production successfully went live at Merck Serono s production plant in Vevey, Switzerland. Werum s worldwide leading Manufacturing Execution System for the pharmaceuticals and biotechnology industry manages and controls the manufacturing of the cancer treatment drug Erbitux, which Merck Serono produces at this site. As the central IT platform, integrates the ERP and two DCS systems, replaces paper-based documentation and ensures efficient, seamless batch and process data flows from process development to commercial production. As a result, Merck Serono has moved a giant step closer to achieving its goal of setting up an integrated biopharmaceutical electronic plant at Vevey. Our biopharmaceutical production benefits considerably from Werum s MES, said Nicolas-Martin Clément, e-plant Manager at Merck Serono. The number of data entry errors has greatly decreased, and with the review-by-exception function we can approve manufacturing records in half the original time. For us, that means a great reduction in the non-value added activities! Against the background of this positive experience, Werum has begun with the implementation of for another new production system in Vevey for Rebif, a drug for treatment of multiple sclerosis. As part of the project, Werum will connect the system to the LIMS system and support the perfusion process with new MES functionalities. In the context of its global MES partnership with Merck Serono, Werum has equipped three production sites with up until now: the biotechnology plant in Vevey as well as the pharmaceutical plants in Darmstadt, Germany and Naucalpan, Mexico. Merck KGaA The oncology drug Erbitux is produced in Vevey, Switzerland. The deployed Weighing & Dispensing solution is integrated with the BPCS ERP system and the Go-Live completes the first phase of a multi-stage MES project at CSL. The next phases of the MES project that are under consideration by CSL involve extending the EBR implementation and then integrating LIMS, LDAP and Siematic PCS7 Process Control Systems in future next steps. Go-Live of Process Development at Novartis Pharma AG Efficiency gains through simplified Process Development oriented recipe modeling at Novartis sites in Basel and Stein The latest version went live at CSL in Melbourne, Australia in a facility for manufacturing blood plasma products. With this being the first installation at CSL in Australia, the Werum MES is now operational at CSL on three continents around the globe. Go-Live at CSL Melbourne, Australia The global pharmaceutical company Novartis is relying on Werum s Process Development Package to develop pharmaceutical manufacturing processes and produce clinical batches at their Swiss GMP pilot plants in Basel and Stein. Novartis can use recipe library elements and machine master data that are preconfigured in the installation for this purpose and thus benefit from simplified and faster process modeling as part of their production studies. Further advantages in terms of flexibility can be gained by using the just recording mode offering full flexibility for technical batches for development but at the same time ensuring collection of all GMP relevant data such as material consumption and equipment usage. Werum s Process Development Package replace a paper-based legacy system. provides standardized interfaces to SAP, which were also implemented during the project. Novartis and its associated companies have been using Werum s already for a long time as a standard Manufacturing Execution System in commercial production, commented Ruth Leu Marseiler, Business Project Lead for the introduction of at Novartis Pharma. Based on the good experience we had in the past we decided to use Process Development that is part of Werum s Manufacturing IT Business Platform as well. Werum developed the Process Development package in close cooperation with Novartis and other pharma companies as part of the activities of the PFU, the User Community. 6 7

5 ... Ready to Go Training Center... Training Center Four questions to Joern Sawinski, Manager Training at Werum, on the new training concept What s new about training? Sawinski: We want to meet the training needs of our customers faster and with more flexibility. As a result, our new training concept is based on standardized modules which cover all functionalities for our customers manufacturing types, such as pharmaceuticals, biotech, chemical APIs. For example: If a customer calls and needs a training course at one of its worldwide production sites the day after tomorrow, we can now literally reach into our training bag, put together the finished training modules and quickly help our customer. Is there a fixed training program? Sawinski: Yes, the new training courses are held at regular intervals and are planned annually in advance. All modules in the program are organized based on role and training focus, which makes it easier for the customer to choose a course. The current training program with all courses and dates for 2013 can be downloaded at Joern Sawinski, Manager Training, Werum Software & Systems AG, Germany Where does the training take place? Sawinski: We conduct the training courses in our modern training rooms at our headquarters in Lueneburg, Germany, or at one of our worldwide locations including the U.S. As an alternative, we will also be happy to offer training courses and workshops locally at our customers plants. Our trainers are subject matter experts with many years of project practice. On request, our trainers will accompany our customers during training courses. Do participants get a certificate? Sawinski: After successful participation in a course, participants receive a certificate naming the training curriculum and the qualification level. Training Tracks Operating Track: The training courses are directed at operators, supervisors, quality management employees, project managers and project employees. Depending on the selected course, they provide an introduction to and present the Business Functions. There are three qualification levels for this track: Basic, Professional and Enhanced. Administration Track: These modules are directed at system administrators, project managers and project employees. This track shows how is administrated and managed for productive operation. Customized Track: In workshops, Werum sets up an individually suitable training program together with its customer and upon request helps with training at the customer s premises. pas-x-trainingcenter.com IMPRINT Publisher Werum Software & Systems America, Inc. 5 Sylvan Way Parsippany, NJ Phone: (973) Fax: (973) info@werum.com