News Release
Werum’s new PAS-X 3.1.8 unites best in class MES
features on latest technology platforms
New capabilities ensure quality and address trends in pharmaceutical manufacturing
Lüneburg, Germany, January 27, 2016 – Werum IT Solutions has released the latest
version of its market-leading PAS-X Manufacturing Execution System (MES) for the
pharmaceutical and biopharmaceutical industries. The new PAS-X 3.1.8 features several
improvements for efficient manufacturing based on the latest technology standards. PAS-X
3.1.8 not only facilitates regulatory compliance, but also supports drug makers to ensure high
quality in their manufacturing processes.
Ensuring manufacturing quality
The latest trends in pharmaceutical manufacturing have been considered and reflected in the
new PAS-X. “PAS-X 3.1.8 is future-ready,” says Robert Welter, Senior Head of PAS-X
Product Management at Werum IT Solutions. “Our user forum PAS-X For Us actively
participated in advancing PAS-X 3.1.8.”
“The use of PAS-X as an MES ensures data integrity and significantly reduces possible data
integrity related issues,” adds Carsten Bierans, Senior Head of Quality Management at
Werum. “Together with the PAS-X For Us working group the MES-related data integrity
positions of the pharma & biotech MES user community are defined.”
Werum continues its usability initiative with a particular focus on quality in shop floor
operations. With PAS-X 3.1.8, the most important material-related functions can now be
accessed more easily and have been given an optimized user interface. Werum also
introduced a dedicated dialog for material reconciliation with built-in best practices. The new
automated material flow overview allows the operator to control the quantities that have been
consumed and processed.
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Improved update capabilities and infrastructure improvements
PAS-X customers will benefit from the significantly reduced downtime needed to update the
software version. A short downtime is crucial for modern bio-pharmaceutical manufacturing
processes. “We reduced the downtime by more than 50%,” says Marcel Ecks, Head of
PAS-X Infrastructure & Development Tools at Werum. “We have achieved this high reduction
rate not only through technical improvements, but through a holistic approach involving both
the process itself and the documentation so that also the qualification efforts could be
reduced.”
PAS-X 3.1.8 allows a cumulative one-step MES product upgrade and data migration. It runs
with the latest platform versions such as Oracle 12. Support of the new OSIsoft PI Event
Frames simplifies integration of shop-floor systems.
Seamless integration of latest PAS-X solutions
PAS-X 3.1.8 allows an even smarter integration of Werum’s proven PAS-X solutions such as
Track & Trace, KPI/OEE and the new Evaluations Package. The new PAS-X Evaluations
Package helps pharma manufacturers unlock the full potential of shop floor data. In PAS-X,
all production-related data and data of the interfaced IT systems converge. Supported by the
integrated and web-based PAS-X Evaluations Package, this combined information can be
used to make production assessments and develop strategies for process optimization.
Simply the best: market-leading MES with all PAS-X 3.1 features
“With the latest PAS-X release, pharma manufacturers benefit from a comprehensive
compilation of innovations, functionalities and usability improvements that Werum introduced
throughout the PAS-X 3.1 family,” says Arndt Erdtmann, Senior Director PAS-X Development
at Werum. For example, Werum customers benefit from automated execution features such
as automated material flow and automated equipment identification, each of which improve
user efficiency and reduce risk of human error. Data integrity is supported by alarm & events,
directly retrieving GMP-relevant exceptions also from level 2 systems and enabling QM to
significantly accelerate the release process of Batch Record Reports through review by
exception. Further acceleration can be achieved by auto-closure functions, which unburden
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QM from checking batches without any exceptions and critical parameters at all, as manual
release is no longer required.
PAS-X 3.1.8 contains the experiences and best practices of decades of successful MES
projects in all areas of the pharma and biotech industries. Several Werum customers have
already decided to incorporate PAS-X 3.1.8. Thorsten Grundmeier, Senior PAS-X Consultant
at Werum, says: “With PAS-X 3.1.8, the most sophisticated and pharma-dedicated MES in
terms of functionality and usability now becomes available on the market for customers in
any region of the globe and from small- to large-scale production. It is simply the best
solution to fully utilize the key benefits of MES for pharma and biotech manufacturers:
compliance, quality and performance.”
Photos:
New dialog for material reconciliation
About Werum IT Solutions
Werum IT Solutions is the world’s 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 but
also by many mid-sized manufacturers. Werum’s manufacturing IT solutions help pharma
manufacturers to increase efficiency, improve productivity, and meet regulatory requirements.
Founded in 1969, the IT company employs about 450 people at its headquarters in Lüneburg,
Germany, and at ten other locations in Europe, America and Asia.
Werum is part of Medipak Systems, the Pharma Systems business area of the international Körber
technology group. Körber unites worldwide nearly 12,000 professionals in industry-leading companies,
achieving annual earnings of more than 2.3 billion Euros. As a Medipak Systems company, Werum
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provides integrated IT solutions for all phases of pharmaceutical and biopharmaceutical production –
including process development, commercial production, and packaging as well as track & trace
serialization.
For more information take a look at our website www.pas-x.com.
Contact:
Dirk Ebbecke
Director Corporate Communications
Werum IT Solutions GmbH
Wulf-Werum-Str. 3
21337 Lüneburg, Germany
Tel. +49 4131 8900-689
Fax +49 4131 8900-20
dirk.ebbecke@werum.com
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