Videos, webinars & downloads
Learn more about Werum's solutions, products and services. Download the latest PAS-X newsletters, brochures, case studies, the PAS-X training program, articles, MES white papers, videos and more.
Products & services
PAS-X Newsletter 2019 Read about our continuously growing portfolio of new software products, features and services helping you to expand your pharma, biotech or cell & gene business. New offerings, for example, are our innovative biometric authentication product K.Me-In to simplify log-in processes, our integrated solution for detailed scheduling, our cloud-based OEE monitoring PAS-X KPI and our new Enterprise Manufacturing Intelligence apps to uncover hidden business value in your pharma factory. In addition to an update on our latest customer projects, you will also find more about our solutions for cell & gene therapy.
PAS-X Newsletter 2018 In our Newsletter we show you, how we have brought three game-changing ideas into reality: PAS-X as a Service – our market-leading MES in the cloud, innovative operating concepts – AR, wearables and voice-directed technology, and our new Enterprise Manufacturing Intelligence solutions. Learn more about how we apply Industrie 4.0 technologies to pharma manufacturing and which Pharma 4.0 solutions we offer. In addition to an update on our latest customer projects, you will also find out more about our new Self-Service Portal, our offering for cell therapy manufacturer, and data integrity.
Werum company profile: fact sheet Werum IT Solutions is the internationally leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Its out-of-the-box PAS-X software product is run by 17 of the world’s top 30 pharmaceutical and biotech companies and in about 800 installations.
PFU: The largest Pharma MES User Community Companies using PAS-X have joined forces with Werum to help develop best-in-class MES technology, functionality and services. The “PAS-X For Us” (PFU) User Community has grown to become the largest Pharma MES User Community worldwide. The aim of the PFU is to work closely with Werum in order to boost future PAS-X functionality and to optimize processes. The community collaborates with Werum experts and other PAS-X users to share experience and best practice knowledge. “The success of PAS-X was able to inspire the largest Pharma MES User Community worldwide and this makes us really proud”, says Rolf Blumenthal, Senior Director Consulting &Training, Werum Software & Systems AG. “All the contributions of the community provide valuable feedback and ideas that are vital for the further development of PAS-X.”
PAS-X: The market-leading MES for pharma & biotech The brochure gives an overview about Werum and our product offering for large multinational as well as regional and mid-sized enterprises. Werum’s manufacturing IT solutions help pharmaceutical and biopharmaceutical manufacturers to increase efficiency, improve productivity, and meet regulatory requirements. The core of our offering is the PAS-X MES solution that combines a functionally complete software, comprehensive services and pre-configured content. Learn more about your benefits when using Werum’s PAS-X MES.
PAS-X Data Access Existing manufacturing data should be optimally used in pharmaceutical and biotech factories as a matter of course. Unfortunately, data scientists spend most of their time collecting and processing data instead of doing things that actually add value. Now with Werum’s PAS-X Data Access customers get curated data from their PAS-X MES that can be consumed and visualized without detailed PAS-X knowledge. You benefit from improved process visibility that is required for decision-making and operational efficiency!
PAS-X Product - Business Functions This document gives a detailed description of all the PAS-X business functions - including Master Batch Records, Finite Scheduling, Weighing & Dispensing, Electronic Batch Recording, Equipment Management, Material Track & Trace, Warehouse Management, Process Quality Control, Corrective & Preventive Actions (CAPA), Operator Training Records, and Manufacturing Intelligence.
PAS-X Weighing & Dispensing solution The PAS-X Weighing & Dispensing solution is a comprehensive package of software functionality, content and training services designed to improve the efficiency of weighing operations. The solution is an easy and cost-effective way to introduce electronic execution and documentation in pharmaceutical manufacturing. It complies with all regulatory requirements and in a reliable and comprehensible way documents the specific input materials, the material quantities and the time of supplying these materials on the shop floor.
K.ME-IN: Smart biometric user authentication With K.ME-IN, Werum offers a smart biometric authentication solution for its market-leading PAS-X Manufacturing Execution System. Users can thus securely and seamlessly authenticate to systems, devices and machines via biometric means such as fingerprint, iris scan, face recognition or a combination of those.
PAS-X KPI For efficient pharmaceutical manufacturing, it is essential for both operators and supervisors on the shop floor and production site managers to constantly monitor operating data. Werum’s PAS-X KPI is a lean, standalone software product for live monitoring of production and packaging lines to improve the shop floor performance of pharma and biotech facilities. PAS-X KPI provides real-time key performance indicators (KPI) to optimize processes or equipment.
Plug & Produce with PAS-X Our Plug & Produce solution allows a fast and easy integration of machines and automation systems into a pharmaceutical production environment – a prerequisite for the implementation of many Industrie 4.0 solutions.
PAS-X Evaluations The “PAS-X Evaluations” Content Package helps to unlock the full potential of shop floor data. Use your data to continuously improve manufacturing processes and to meet regulatory compliance requirements. PAS-X Evaluations enables you to generate knowledge about manufacturing operations at any time. Shop floor personnel are able to identify opportunities for improvement and to report evidence of improvements.
Finite Scheduling PAS-X Finite Scheduling – now powered by sedApta’s Factory Scheduler, whose standard functions are seamlessly integrated into PAS-X MES – is covering the production planning process. The function enables the detailed scheduling of your production processes and resources with finite capacity, the optimization of production sequences as well as the management of materials and multi-scenario analyses. Benefit from a higher quality of scheduling results with real-time feedback, less implementation effort thanks to a pre-tested, out-of-the-box interface, joint master data management and high visibility across multi-tier networks to reduce inventory.
PAS-X Monitoring For efficient pharmaceutical manufacturing administrators and managers must have a comprehensive view of all technical PAS-X components. To ensure system performance and stability, they need to constantly collect data from all relevant points in the technical PAS-X landscape. Werum’s PAS-X Monitoring provides just the right tools to meet this challenge. It combines well-placed sensors with powerful functions that process incoming data to present useful information and keep the production running.
PAS-X Track & Trace solution Werum offers a Track & Trace solution to comply with anti-counterfeiting requirements for the pharmaceutical industry. PAS-X 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. PAS-X Track & Trace is a smart option to get started with our manufacturing IT solutions and can easily be extended to become the PAS-X Packaging Solution.
Integrated IT Solution for Packaging 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-first-time operation - Optimize performance of the packaging process including changeover - Manage the serialization and aggregation process In order to meet these challenges, Werum supports pharma and biotech companies with its All-in-One PAS-X Packaging Solution – a combination of PAS-X software functions, PAS-X Content Packages and PAS-X Services relevant for packaging operations out of the box. It is a smart option to get started with Werum’s Manufacturing IT solutions.
Cell & Gene Therapy with PAS-X MES The past few years have seen rapid growth in the number of cell therapy products in late stages of clinical trials. However, moving closer to market approval brings significant operational challenges and risks for companies as their patient populations grow. Electronic systems are emerging as the only viable option for managing large product volumes where mistakes can be disastrous. Werum’s PAS-X is ideally suited to target key challenge areas for cell therapy manufacturers.
RImanager RImanager is a centralized master data driven Regulatory Information Management solution, which provides organizations the capability to manage their product portfolio with effortless compliance. It allows you to manage your master data as well as to plan and track related regulatory data, activities, processes, submissions and commitments across departments on a global scale. With RImanager you will have all your regulatory affairs activities transparent at anytime and anywhere.
Enterprise Manufacturing Intelligence (fact sheet) Through Werum’s Enterprise Manufacturing Intelligence apps data from a variety of sources will be accessed and evaluated using state-of-the-art algorithms and visualizations. Intelligent data analysis for your manufacturing facility allows a wide range of applications – from automated report generation to predictive analytics and even real-time process interaction.
AstraZeneca digitizes manufacturing with Werum’s PAS-X MES AstraZeneca had a diversified MES landscape in place, ranging from paper-based to various legacy systems. To harmonize this environment, the company opted for Werum as its preferred MES supplier. AstraZeneca’s standard MES core program aims to use a common technology platform alongside standards and guidelines to help drive business process standardization. The goal is to have a single software version in all manufacturing sites, thus reducing development effort, rollout times and maintenance costs. The standardized PAS-X usage allows the creation of global content and implementation services.
PAS-X KPI supports Lean Six Sigma and OEE improvements at leading pharma player A leading global pharmaceutical company has introduced Lean Six Sigma for their worldwide network. As part of the initiative, the operations team focused on capturing and driving OEE improvements throughout the plant. The company decided to use Werum’s PAS-X KPI solution that provides seamless connectivity to the existing PAS-X MES. All batch data is acquired from PAS-X automatically, resulting in accurate KPI measurements with minimal input from operators. The pharma manufacturer benefits from improved operational efficiency and visibility of the shop floor operations.
AstraZeneca uses Werum’s PAS-X MES to replace SAP PI Sheets AstraZeneca Australia uses Werum’s PAS-X MES at their site in North Ryde, just north-west of Sydney, as the leading IT system in production. The goal of the PAS-X implementation was to replace the custom SAP Process Instruction Sheets which supported the end-to-end manufacturing, QA and QC operations and electronic batch recording – without any disruption to running operations and the supply of critical products. PAS-X also provides a standard interface to the new regional AsiaSAP ERP system.
Japanese vaccines manufacturer UNIGEN implements PAS-X at one of the largest biotech plants in only four months UNIGEN set up a greenfield site in Ikeda, Gifu, Japan, which is one of the largest plants for contract manufacturing of recombinant influenza vaccines. PAS-X was chosen as the MES for the new plant because it allows a fast-track implementation and flexible MBR creation. Within a record time of only four months after completing the “Fit Phase”, it was delivered to the customer – fully tested and with the entire user interface in Japanese. PAS-X now controls an innovative and complex biotechnological manufacturing process called Baculovirus Expression Vector System (BEVS).
World market leader in diabetes care relies on Werum’s PAS-X at eight sites around the globe MES systems will become increasingly important as pharmaceutical companies look for global standardized and integrated IT solutions. A large pharmaceutical company based in Scandinavia had to replace manual business processes as well as its outdated MES/ERP system. Since the first rollout in Denmark, PAS-X became the standard MES at the Werum customer and plays a major role in the company’s largest ever IT initiative to install a globally standardized ERP/MES solution. Werum’s successful PAS-X installations at eight of the customer’s sites have confirmed the ability of PAS-X to optimize and standardize manufacturing processes across sites ensuring cost-efficient production and absolute batch consistency. In future, the pharma major and Werum will embark on further PAS-X rollouts and continue their combined strategy for success.
Uncompromising Quality CAPA and Workflow Management DEV@COM is a CAPA system specifically tailored and customized for Bayer HealthCare. The pharma group uses this application to manage de-viations, complaints and corrective and preventive actions both in the production environment and the further life cycle of pharmaceutical products. After its implementation, Werum has further expanded DEV@COM by adding additional workflows and now markets the system under the name PAS-CAPA as a product of its PAS-X MES portfolio. The project report provides an overview of the de-velopment process from the first project phase to the marketable product and focuses on the various available workflows and the remarkable product features.
Werum Helps Genzyme Production go Paperless In the course of Genzyme's expansion of its Waterford facility the company decided to increase the level of automation in order to achieve a paperless manufacturing supply in various areas including the Warehouse, Oral Dose, Packaging, Quality Control, and Fill Finish, starting with a paperless EBR (electronic batch recording). This brochure describes the deployment of Werum's Manufacturing Execution System PAS-X in Genzyme's facility, its functional focus, and the benefits of a paperless production. The brochure also explains why Genzyme selected Werum's PAS-X software product as the corporate standard for MES systems.
Biotechnical Production at Boehringer Ingelheim Over the last year, no other project in Europe's pharmaceutical industry has gained as much notice as the new active ingredient plant of Boehringer Ingelheim in Biberach. As the largest cell culture plant in Europe, it set a new record in development and construction, and currently surpasses all others in terms of technology. This brochure describes the employment of Werum´s Manufacturing Execution System PAS-X BIOTECH at Boehringer and how it ensures mastery of the complex workflows in biopharmaceutical production. The brochure explains how PAS-X meets the particularly high demands in the production of active pharmaceutical ingredients (API).
Bayer HealthCare Quality in Each and Every Tablet Since 1999, Bayer HealthCare in Leverkusen, Germany, has been operating its manufacturing plant for pharmaceutical solids with the production management system PAS-X by Werum. This brochure describes, how the well-proven system supports paperless production and enables electronic execution workflows, documentation and approval of batch records. Due to mobile RF terminals the operators can freely move in the whole plant while being safely guided through the entire production process. Just by a click of a button operators can acquire relevant order and batch data and execute them.
Case Study Novartis - Global MES Rollout Strategies As a leading and experienced MES-Provider for the pharmaceutical and biopharmaceutical industry Werum has put a special focus on optimizing the procedures in MES projects. As part of Werums approach, the company encourages customers to follow a global multi-site MES-strategy. This case study describes how customers can benefit from a successful overall rollout scheme by presenting the top ten pharmaceutical company Novartis as a model.
Articles & white papers
How an MES supports your business continuity during an acute crisis Business continuity relies on resilience: the ability to successfully deal with crises like COVID-19, to keep manufacturing and supportive business processes alive and to adapt to environmental changes. Pharma and biotech manufacturers who invest in their resilience gain competitive advantages. In this context, MES play a pivotal role and prove to be true game changers: By digitizing production processes, they enable remote operations and services – providing the basis for the necessary flexible process design and adaptation, for automated real-time production and quality control, and for fast and informed decision-making.
Werum honored with Frost & Sullivan Customer Value Leadership Award Based on its recent analysis of the global manufacturing execution system (MES) market for pharmaceuticals, biotechnology, and cell & gene therapies, Frost & Sullivan recognizes Werum IT Solutions with the 2019 Global MES for Pharmaceuticals, Biotechnology, and Cell & Gene Therapies Customer Value Leadership Award. Its MES solution, PAS-X, supports complex operations, higher productivity, and adherence to regulatory requirements. Its end-to-end solution comprises the PAS-X software product, pre-configured content for pharma and biotech processes, as well as consulting, training, and support services.
5 benefits of using an MES for pharma & biotech manufacturing Why should pharma and biotech companies use a manufacturing execution system? The short answer is: MES offer substantial improvements over paper-based processes. They help companies create flawless manufacturing processes, reduce risks, time, costs and effort, and increase process efficiency and product quality. In addition, they provide real-time information and are a prerequisite for digitization and Pharma 4.0.
Applying a holistic control strategy in Pharma 4.0 The ISPE “Pharma 4.0” Special Interest Group has designed an operating model as a framework for how digitization can be applied to ICH Q8–Q12 and named it the “holistic control strategy”. The term refers to an integrated approach to product and process lifecycle management and ongoing change management covering both the development chain and commercial manufacturing. This Pharmaceutical Engineering article introduces the model and presents two case studies of pharma companies that have started to apply it.
Bringing Pharma 4.0 into the world: Christian Wölbeling, Werum/ISPE, in portrait The pharma industry certainly has its Pharma 4.0 champion in Christian Wölbeling, a 56-year-old IT expert. Starting with ideas jotted down on a restaurant napkin, he has tirelessly and expertly led ISPE’s global efforts to define the industry’s slow but sure progression toward a holistic control strategy to achieve the Pharma 4.0 goal. This Pharmaceutical Engineering article shows how ISPE is trying to bridge the Industry 4.0 automation concepts with the pharma-specific ICH guidelines to enable the agile and compliant manufacturing of high-quality pharma products.
AI in tomorrow’s pharma and biotech industry Artificial Intelligence (AI) is currently revolutionizing the healthcare system, in which AI-based software is increasingly becoming a part of medical procedures. AI will also play a key role in pharmaceutical manufacturing, helping companies to optimize processes. However, in pharma production, only validated software may be used – but the rules required for AI systems have not yet been fully established. Our whitepaper reveals how pharma and biotech manufacturers can nevertheless use AI to uncover hidden business value in their factories.
Return on investment: What is the cost of not doing MES? Many pharma and biotech manufacturers struggle to gain senior level buy-in for MES investments. Whilst corporate IT such as ERP is well understood, not believing in a Return On Investment for manufacturing solutions is a major reason why companies have difficulties to eliminate paper GxP records. MES digitizes end-to-end manufacturing processes and offers great opportunities for process improvements and efficiency savings. In our white paper you will learn more about major saving areas with MES and typical steps to evaluate ROI.
How to Speed Up Cell and Gene Therapy Treatments for Patients PAS-X: Electronic batch records increase quality through standardization and elimination of paper, while equipment, inventory and material management streamline the process. This white paper addresses the unique production problems of cell and gene therapy and explains how a manufacturing execution system (MES) can address them. It provides guidance on how to select an MES and a case study of two CAR-T therapy companies scaling up with and without an MES.
The pharma industry’s traceability movement Counterfeit drugs have become an increasing global threat. In this article, published by Pharmaceutical Processing, Werum’s Jürgen Laskowski and Zaim Imeraj explain how track-and-trace solutions provide all necessary features for the serialization and aggregation of medical products in packaging processes. When integrated into MES drug manufacturers benefit from additional advantages of comprehensive production control and documentation, including equipment management.
Plug & Produce: Your entry point to Pharma 4.0 Werum IT Solutions together with the Medipak Systems companies Dividella, Mediseal and Seidenader and other vendors and partners like ISPE is working on a solution for the structured data exchange between the production management software and the equipment in a pharmaceutical plant: “Plug & Produce” is our vision for a new industry standard which will enable the fully networked industrial pharma production – Pharma 4.0 – in the future.
Embracing paperless production PAS-X MES from Werum IT Solutions could hold the answer to transforming paperbased production at South African pharmaceutical manufacturers. Abby Vorster from P&C Review speaks to Albert Landman, the company’s manager for sales and business consulting, about the benefits of paperless manufacturing and this leading IT solution.
GAMP® 5: Alternative Software Development Models and Methods in GxP Environments Article from Pharmaceutical Engineering 1/2012 The article examines whether new software development methods such as Scrum, XP, CRP and MDA meet the regulatory requirements for software programming. Software developers and users are provided with recommendations on how alternative software development techniques can be used in regulated industries. The authors - one of them Rolf Blumenthal, Senior Director of Consulting & Product Management with Werum, - show what documentation the software tools provide and compare their scope with the GAMP 5 specifications.
IT Focus: The Great Mediator How MES can optimize the pharma supply chain Article from Contract Pharma 3/2012 Manufacturing Execution Systems (MES) mediate between business administration - such as sales and production planning - and the automation of the production process. They play a big role for big pharma: controlling, optimizing and documenting business processes executed on facility floors in full compliance with pharmaceutical requirements, regulations and restrictions. In his article, author Rolf Blumenthal, Senior Director of Consulting & Product Management with Werum, shows which benefits the pharma industry can derive from MES - e.g. regarding the architectural design of pharmaceutical production, integration of equipment and regulatory requirements.
Boosting Production Efficiencies: Werum Interview about MES and PAS-X in PharmaAsia Magazine In an interview with PharmaAsia , Dietmar Mueller, Head of Sales Asia-Pacific, Werum IT Solutions (previously Werum Software & Systems AG), talks about how manufacturing execution systems (MES) are helping pharmaceutical manufacturers further improve and boost the efficiency of their production processes. With PAS-X Werum offers a complete package that includes the software product, comprehensive services and pre-configured content providing all major MES functionalities required by the pharma and biotech industry "Out of the Box".