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Products & services
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, biopharmaceutical and cell & gene industries. Its PAS-X software product is run by the majority of the world’s top 30 pharmaceutical and biotech companies and many regional and mid-sized manufacturers.
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. Werum regards the PAS-X User Forum as a competent business partner providing practical ideas for further advancing the PAS-X MES. Companies actively contributing to the PAS-X User Forum gain a competitive advantage through the exchange of profound technical knowledge.
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 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 for companies as their patient populations grow. Electronic systems are emerging as the only option for managing large patient volumes. Werum’s PAS-X MES is ideally suited to target the key challenges for Cell & Gene 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.
How Werum PAS-X Savvy revolutionizes managing, analyzing and reporting of your pharma and biotech process data Manufacturing of pharmaceutical and biopharmaceutical products is a complex process that can be disrupted by many factors such as raw materials, human interactions or aging equipment. At the Körber Business Area Pharma we can deliver the difference along the pharma value chain with our unique portfolio of integrated solutions. Our data analytics and AI solutions accelerate product commercialization and uncover hidden business value.
Successfully implementing Werum PAS-X Savvy Get familiar with our bioprocess software implementation strategies and accelerate your process data analytics
Werum PAS-X Savvy for bioprocess data management Bioprocess data analytics to accelerate your product commercialization
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.
New England Biolabs streamlines process validation & verification Consolidated data processing platform / Greatly reduced effort for data collection from different sources / Process intelligence supports efficient process development and faultless production runs
Root cause analysis in continued process verification with PAS-X Savvy Automated data collection and harmonization / Multidimensional analysis of multiple batches across unit operations / Reliable identification of deviations and their root causes
Taking review-by-exception to the next level Leading contract manufacturer SteriPack benefits from fast-track implementation and auto-batch release
Sharp Packaging's experience implementing Werum PAS-X MES As a global leader in contract pharmaceutical packaging and advanced clinical supply chain services, Sharp Packaging has developed a reputation for expertise, innovation and superior customer service. Striving for quality first and recognizing the benefits digitization could offer its customers, Sharp has implemented Werum PAS-X MES in their Heerenveen, Netherlands packaging plant.
How PAS-X MES kept AstraZeneca’s manufacturing operations running during COVID-19 AstraZeneca has deployed Werum PAS-X MES on a global scale as their standard MES. PAS-X is running in multiple pharma and biotech sites across Europe, the US and Asia. In an interview Corby Kassebaum, PAS-X Business Lead at AstraZeneca’s biologics manufacturing facility in Frederick, Maryland, USA, explains how COVID-19 impacted their manufacturing operations and how PAS-X enabled production and quality teams to access the system remotely.
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 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.
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).
Articles & white papers
ISPE Pharma 4.0™ SIG and its working groups By Christian Wölbeling and the ISPE Pharma 4.0™ Special Interest Group Working Group Leads The ISPE Pharma 4.0™ Special Interest Group (SIG) launched in 2015 to provide a road map for new challenges of digitalization, Industry 4.0, and the smart factory. The SIG addresses how pharmaceutical industry stakeholders, including regulatory authorities, can achieve benefits from Pharma 4.0™ initiatives.
How to ensure a holistic process characterization in biotech & pharma Constant, reliable product quality is a must for pharmaceutical and biopharmaceutical manufacturing. Regulatory authorities require drug manufacturers to consistently deliver product quality through validated processes in order to achieve product approval. Process characterization is a central cornerstone and the first stage of process validation (PV). Hence, failing to efficiently plan and execute activities on that stage leads to increased time-to-market.
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.
How digitization helps cell & gene manufacturers Interview with Rachit Jain, Global Cell and Gene Lead Software, Körber Business Area Pharma Why is digitization important for cell & gene therapy manufacturing? How is Werum PAS-X MES unique amongst all the automation solution providers when it comes to C&G?
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.
Werum IT Solutions: Revolutionizing Production in the Biotech Industry The digital revolution and industrialization have changed the pharma and biotech market drastically over the years. It is providing opportunities for all market players. However, it has also brought challenges like increasing quality and regulatory requirements, shrinking batch sizes, and demand for cost-efficient solutions. Though the need for pharma and biotech products has significantly increased, there are several challenges in the manufacturing sector.
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.
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.
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.
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.
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.