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The pharma & biotech industry has been significantly affected by COVID-19. Digital advancement and MES systems are becoming more important than ever as traditional manufacturing processes are limited and inflexible.
MES plays a crucial role in this global crisis by enabling Workforce 4.0 and continuous manufacturing.
Cell Therapy and Gene Therapy: A Case Study on scaling up for Commercial Manufacturing
Cell Therapy and Gene Therapy: A Case Study on scaling up for Commercial Manufacturing, presented by Mucahit Agirtmis, Sales & Business Consultant, Werum IT Solutions
Data Integrity and the Manufacturing Control Strategy
Data Integrity and the Manufacturing Control Strategy, presented by Steve Murray, Principal Consultant, Werum IT Solutions

ユースレター

PAS-Xニュースレター 医薬品製造の拡張を支援する新しいソフトウェア製品、機能、およびサービスにおいて成長を続けるポートフォリオについてお読みください。私たちは、バイオテクノロジーおよびセル&遺伝子療法用に明確に構築された新しいPAS-X 3.2バージョンをリリースします。革新的な製品とは例えば、ログインプロセスを簡素化する生体認証製品K.ME-IN、詳細なスケジューリングを行う統合ソリューション、PAS-X KPIを監視するクラウドベースのOEE、工場に隠されたビジネス価値を発見する新しいEnterprise Manufacturing Intelligenceアプリなどです。最新の顧客プロジェクトに加えて、当社のセル&遺伝子療法向けソリューションについてもご覧いただけます。私たちの活動は報われます:三度目となる名誉あるフロスト&サリバンアワードを受賞しました! Download (1.3 MB)
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. Download (669.3 KB)
PAS-X Newsletter Asia 2018 In our Asia 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. Download (1.5 MB)
PAS-Xニュースレター 2017 今回のニュースレターでは、Werumが医薬品製造にインダストリー4.0の技術やどういったファーマ4.0ソリューションを提供するかをご説明します。EMI (エンタープライズ製造インテリジェンス)やサービスとしてのPAS-Xから Plug & ProduceやSmart Devices(多機能端末)に至るまでまたWerumが提供する新サービス、アジア地区で強化された活動、最近の顧客プロジェクトなどについてもご説明します。 Werumが提供するソリューションは、2年連続のAsian Manufacturing Award(アジア製造賞)に続き、Frost & Sullivanの著名なGlobal Technology Leadership Awards(グローバルテクノロジーリーダーシップ賞)も 受賞することができました。 Download (676.2 KB)
PAS-X Newsletter 2015 Our newsletter provides information about our latest customer projects and PAS-X solutions. Learn more about the benefits of the PAS-X KPI solution in combination with Medipak packaging machines and our integrated MES software/HMI hardware solution which we developed with the hardware provider Systec & Solutions. Other topics of this issue: the future of biopharmaceutical manufacturing, news from the Werum Academy and the introduction of your new MES consultants in South America and Japan. Download (2.4 MB)
PAS-X Newsletter 2014 Learn more about the importance of usability for the further development of PAS-X and the usability improvements of the upcoming V3.1.7 version. This issue also provides an update on our latest customer projects and our manufacturing IT solutions for packaging and KPI. In an interview, find out more about the role of Werum within the Körber Medipak Systems Group and the resulting benefits for our customers. Finally, we present how leading mid-sized pharma and biotech companies benefit from PAS-X out of the box. Download (1.8 MB)

資料

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. Download (380.2 KB)
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. Download (566.7 KB)
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. Download (2.3 MB)
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! Download (566.2 KB)
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. Download (4.8 MB)
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. Download (287.4 KB)
K.ME-IN: 製薬およびバイオテクノロジー工場向けのスマートバイオメトリックユーザー認証 K.ME-INを使用して、Werumは市場をリードするPAS-X製造管理システムにスマートな生体認証ソリューションを提供します。したがって、ユーザーは、指紋、虹彩スキャン、顔認識、またはそれらを組み合わせた生体認証手段を介し、システム、デバイス、および機械に対し安全かつシームレスに認証できるようになります。 Download (882.8 KB)
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. Download (645.5 KB)
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. Download (1.5 MB)
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. Download (1.8 MB)
ファイナイトスケジューリング(Finite Scheduling) PAS-X ファナイトスケジューリング- sedApta社のFactory Schedulerの標準機能がPAS-X MESにシームレスに統合され、生産計画プロセスを実行するようになります。 .この機能で製造プロセスとリソースの有限能力を詳細に計画することが可能となり、生産の順序と原材料管理の最適化や複数の計画分析が可能となります。こうした高品質の計画により、複数の生産拠点を持つ企業のマスターデータの中央での管理や計画の透明性の確保がリアルタイムでフィードバックされ、在庫低減が実現します。 Download (1.6 MB)
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. Download (513.4 KB)
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. Download (221.7 KB)
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. Download (4.6 MB)
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. Download (3.3 MB)
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. Download (357.4 KB)
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. Download (1.7 MB)

ケーススタディー

PAS-X KPIは総合設備効率(OEE)の改善手法としてリーンシックスシグマを用いて大手製薬会社をサポートしています 世界的大手製薬会社が、世界中のネットワークにリーンシックスシグマを導入しました。イニシアチブの一環として、運用チームはプラント全体でOEEの改善を把握し、それを推進していくことに焦点を合わせました。同社は、既存のPAS-X MESへのシームレスな接続を提供するWerumのPAS-X KPIソリューションの使用を決定しました。すべてのバッチデータはPAS-Xから自動的に取得されるため、オペレーターからの最小限の入力で正確なKPI測定が行われます。製薬会社は、作業効率の改善および製造現場の可視性による恩恵を受けます。 Download (248.5 KB)
アストラゼネカがWerumのPAS-Xを使った製造のデジタル化を決定 アストラゼネカのMES分野には紙ベースからさまざまな旧来の多様なシステムがありました。こうした環境を調和化するために、アストラゼネカはWerumを優先サプライヤーとして選択しました。アストラゼネカ標準のMESコアプログラムの目標は、ビジネスプロセスの標準化を進めるための標準やガイドラインに則して共通の技術基盤を使えるようにすることです。ゴールはすべての製造サイトで同じバージョンのソフトウェアを使うことです。これにより開発作業、導入期間および運用費用の削減を図ります。標準化されたPAS-Xの活用によりグローバルレベルでコンテンツや導入サービスの実施が可能となります。 Download (435.5 KB)
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. Download (425.3 KB)
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). Download (1.9 MB)
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. Download (712.1 KB)
Bayer Healthcare: 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. Download (478.3 KB)
Genzyme: 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. Download (625.1 KB)
Boehringer Ingelheim: 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). Download (2.4 MB)
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. Download (2.3 MB)
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. Download (2.3 MB)

記事&ホワイトペーパー

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. Download (1.6 MB)
Werum がフロスト&サリバン カスタマーバリューリーダーシップアワード2019を受賞 医薬品、バイオテクノロジー、セル&遺伝子療法のグローバル製造実行システム(MES)市場の最近の分析に基づいて、医薬品、バイオテクノロジー、およびセル&遺伝子療法向け2019グローバルMESを提供するWerum IT Solutionsはフロスト&サリバンのカスタマーバリューリーダーシップアワードを受賞しました。そのMESソリューションであるPAS-Xは、複雑な運用、生産性の向上、そして規制要件の順守をサポートします。エンドツーエンドのソリューションは、PAS-Xソフトウェア製品、製薬およびバイオテクノロジープロセス向けの事前設定コンテンツ、コンサルティング、トレーニング、およびサポートサービスから構成されています。 Download (1.7 MB)
製薬およびバイオテクノロジー製造にMESを使用する5つのメリット 製薬会社とバイオテクノロジー会社がMESを必要とする理由とは?簡潔な答えは次のとおりです:紙ベースで製造実績記録を作成するプロセスに対し、MESを利用して電子化された落ち度のない製造プロセスを運用すると、以下の点が大幅に改善されます。リスク、時間、コスト、労力を削減し、製造効率と製品品質を向上させます。さらに、電子化されたリアルタイム情報が提供されることで、ファーマ4.0へ進むための基盤となります。 Download (913.3 KB)
ファーマ4.0における総体的な対応戦略の適用 ISPE「ファーマ4.0」専門部会(SIG)は、ICH Q8–Q12にデジタル化を適用する方法のフレームワークとしてオペレーティングモデルを設計し、「総体的な対応戦略」と名付けました。この用語は、製品とプロセスのライフサイクル管理、および開発チェーンと商業生産の両方を対象とした継続的な変更管理に対する統合アプローチを指します。この「Pharmaceutical Engineering」誌の記事では、同モデルを掲載し、適用を開始した製薬会社の2つのケーススタディを紹介します。 Download (521.8 KB)
ファーマ4.0を世界に導入:Christian Wölbeling、Werum/ISPE、ポートレート 製薬業界には、56歳のIT専門家であるファーマ4.0チャンピオン、Christian Wölbeling氏がいます。彼は、レストランのナプキンに記したアイデアを基に、ファーマ4.0の目標を達成するための総体的な対応戦略に向けた業界の地道な進歩を明確化するISPEのグローバルな取り組みをたゆむことなくかつ専門的に主導してきました。この「Pharmaceutical Engineering」誌の記事には、高品質な医薬品の迅速かつ規格に対応した製造を実現するために、ISPEがどのようにインダストリー4.0の自動化コンセプトならびに製薬固有のICHガイドラインを橋渡ししているかが紹介されています。 Download (282.8 KB)
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. Download (864.5 KB)
費用対効果:MESを行わない場合の費用はいくらですか? 多くの製薬およびバイオ医薬品製造企業は、MES投資に対する高水準の賛同を得るのに苦労しています。ERPなどの企業ITは十分に理解されていますが、製造ソリューションに対する費用対効果を信じない主な理由は、企業にとって紙のGxPレコードを削除することが困難であるということにあります。MESは、エンドツーエンドの製造プロセスをデジタル化し、プロセスの改善と効率化への大きなチャンスを提供します。ホワイトペーパーでは、MESを使用した主要な節約領域とROIを評価する一般的な手順について詳しく説明します。 Download (598.5 KB)
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. Download (690.7 KB)
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. Download (94.1 KB)
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. Download (2.0 MB)
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. Download (738.3 KB)
Boosting Production Efficiencies: Werum Interview about MES and PAS-X in PharmaAsia Magazine In an interview with PharmaAsia, Dietmar Müller, 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". Download (48.7 KB)
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. Download (189.8 KB)
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. Download (1.6 MB)