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News Release Werum Software & Systems AG, 10/31/2006 Bayer HealthCare API Page 1 of 2 News Release October 2006
Bayer HealthCare runs Active Ingredient Production with PAS-X Third MES by Werum in Operation at Wuppertal Site
Lueneburg, Germany, October 31, 2006 – A third active ingredient plant
has been furnished with a PAS-X system by Werum Software & Systems
at the Bayer HealthCare production site of Wuppertal-Elberfeld (Germany).
The first installation of a PAS-X system with Bayer took place in 2000 – so
paperless active ingredient production at this site has already become a
tradition.
With its core function of Electronic Batch Recording (EBR) the MES guides the user through the manufacturing process and checks manually acquired data for plausibility when entered. The PAS-X system continually monitors the stipulated process flow; it also offers forecast functions to show deviations at a very early stage and documents unexpected events. This is the basis for Bayer to conduct statistical evaluations enabling them to continually improve the quality of their processes. PAS-X is designed to ensure complete, GMP-compliant, and searchable documentation and archiving of production runs. All batch documentation is automatically checked for completeness. Connected to PAS-X are two subordinate SCADA systems by ProLeit and ABB. With the roll-out of PAS-X paper-based documentation had to yield to electronic documentation. The regular production briefings are now taking place at the EBR system. At its production site in Wuppertal-Elberfeld Bayer produces more than 20
different active ingredients. Among them are active ingredients for drugs to
treat coronary heart diseases like the well-known Adalat®, for the
antibiotics Ciprobay® and Ayalox® as well as for the biotechnologically
produced Glucobay®. Substances employed in veterinary medicine
complete the range of products.

Werum Software & Systems
is a leading supplier of Manufacturing Execution
Systems for the pharmaceutical and biopharmaceutical industry worldwide.
Twelve of the world's top 20 pharmaceutical companies and leading biotech
companies use Werum's product suite PAS-X to run their manufacturing business.

News Release Werum Software & Systems AG, 10/31/2006
Bayer HealthCare API
Page 2 of 2
Outstanding PAS-X features are the functions ensuring compliance and boosting
performance. The modular system suite includes components for Production
Planning and Scheduling, Master Batch Record Management, Electronic Batch
Recording, Weighing and Dispensing, Material Flow Control and Tracking,
Equipment Integration, Warehouse Management, Quality Management, and
Performance Management based on KPI Analysis. Werum’s solutions and
services range from software consulting, creation of functional specifications, and
software development to turn-key delivery of integrated and validated
Manufacturing Execution Systems. Founded in 1969, the IT company employs
more than 250 people in its headquarters in Lueneburg, Northern Germany, the
regional offices in West and Southwest Germany, and the subsidiary in
Parsippany, New Jersey, USA.

Contact:
Volker Mensing
Director of Communications

Source: http://www.werum.sg/pdf/mesnews/NR_Bayer_HealthCare_API.pdf

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