Latest news

OPEN-SCS plug fest took place in Lüneburg on invitation of Werum IT Solutions / Successful testing of interfaces, interoperability, and compliance adherence / OPEN-SCS honored with Pharma 4.0 Award

Shawn Opatka assumes new role as Executive Vice President and General Manager of Werum IT Solutions America, Inc.

Go-live of Werum’s PAS-X MES at Takeda’s API production site in Grange Castle, Ireland / Successful transformation to paperless factory / Huge benefits in quality, regulatory compliance, operations and data availability / PAS-X SAP interfaces for seamless data exchange

Strategic partnership to develop a “vein-to-vein” digital supply chain solution suite integrating manufacturing / Cell and Gene Therapy players benefit from standardization, scalability and compliance / Werum’s PAS-X MES plays decisive role

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The Pharma Manufacturing Blog

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Shawn Opatka

Phone: +1 973 646-3408

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How a state-of-the-art MES saves time & effort and avoids risk in your pharma factory

Paper-based manufacturing processes in pharma or biotech are slow, error-prone and costly. On average 20% of batch deviations are caused by human error!

An MES helps you to avoid these shortcomings. It guides your operators through the production process and controls every step. QA reviews batch records in a matter of minutes instead of hours!

Learn more about how to improve efficiency and compliance in your pharma or biotech factory:

Contact our experts        Download our whitepaper

Case study

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.

Upcoming events

Date/Location Event/Webinar
24 Oct - 25 Oct 2019
Lüneburg, Germany
European PAS-X User Group Meeting 2019
05 Nov - 07 Nov 2019
Wuhan International Exposition Center, China
China International Pharmaceutical Machinery Exposition, booth #S1-04
05 Nov - 07 Nov 2019
Frankfurt, Germany
CPhI Worldwide, hall 11.0, booth #G13
06 Nov - 07 Nov 2019
Singapore
Cell & Gene Therapy APAC 2019 (co-located with The 5th Annual Biopharma Development & Production Asia Pacific Conference)
12 Nov - 13 Nov 2019
Berlin, Germany
7th Serialization Symposium

Empowering Pharma 4.0

Systems, equipment, and personnel have become increasingly interconnected in the digital economy, offering new opportunities for the pharma and biotech industries. Together with our fellow Medipak Systems companies and other partners, Werum IT Solutions is working on innovative solutions to make Industrie 4.0 a reality in pharma.

PAS-X Newsletter

Cloud-based MES, innovative control concepts, EMI, Pharma 4.0, new reference projects, Self-Service Portal, cell therapy, data integrity

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.

From Industry 4.0 to Pharma 4.0: ISPE Article of the Year

The current submission-based control strategy does not consider GMP, facilities, equipment and other production-specific controls to mitigate risk and ensure an effective, reliable production process. Transforming today’s control strategy to commercial manufacturing by technology transfer and scaling requires a best practice methodology that will change the current control strategy into a holistic production control strategy.

In their article, which received the ISPE 2017 Article of the Year award, the authors Christoph Herwig, Christian Wölbeling and Thomas Zimmer identify the need for a redefined control strategy implementation methodology.

Read more at Pharmaceutical Engineering

A planned stop or a technical problem? Every stop in production raises questions and requires quick and reliable answers. The PAS-X KPI software provides pharmaceutical and biopharmaceutical manufacturers with important data and key figures in real time. This allows to identify weak points at a glance and to improve the efficiency of production and packaging lines.

The world’s leading pharma & biotech MES

Werum IT Solutions is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries.

Our PAS-X software product is run by the majority of the world’s top 30 pharmaceutical and biotech companies and also by many mid-sized manufacturers. 

 

PAS-X Software

Jobs: Join our team

Whether it's in software development, consulting or exciting projects – at Werum IT Solutions, a global leader with sustainable growth and room for innovative ideas, you have the chance to contribute your expertise and make a difference.

 

Jobs & careers

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Werum IT Solutions GmbH / Wulf-Werum-Str. 3 / 21337 Lüneburg / Germany

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