Web-based Software helps optimize quality management.
Press Release Summary:
PAS-CAPA system maps procedures and electronically executes workflows required when deviations occur during manufacturing process of pharmaceuticals. Fully compliant with GMP requirements, integral functions support quality management in terms of acquiring, assessing, and documenting deviations, revisions, and customer complaints; observations during tests; requests for changes; and resulting correction and prevention actions (CAPA). Audit and reporting capabilities are also provided.
Original Press Release:
Bayer HealthCare AG Introduce Werum IT System to Optimize their Quality Management
'Corrective and Preventive Actions' (CAPA) and 'Complaint Management' are the core functions of this new system
Lueneburg, Germany, November 16, 2005 - Werum Software & Systems has implemented a web based software system to enhance quality assurance at the Bayer HealthCare AG. The PAS-CAPA system electronically executes the workflows required when deviations occur during the manufacturing process of pharmaceuticals. Moreover, it maps the procedures to handle technical product complaints. In full compliance with GMP requirements, the integral PAS-CAPA functions thus support quality management: The application acquires, assesses and documents deviations, revisions and customer complaints, observations during tests as well as requests for changes, and of particular importance the resulting correction and prevention actions (CAPA).
Werum and Bayer Technology Services (BTS) have closely cooperated during the technical development and implementation of the system. The partnership between BTS and Werum, which started in April 2004, focuses on the installation of Manufacturing Execution Systems in regulated industries. The project at Bayer HealthCare is the first IT solution jointly designed and implemented by BTS and Werum.
In addition to the management of users, addresses and master data as well as an audit trail function, PAS-CAPA offers analysis and report building capabilities as core system functions. Since this software product is web based, users call up the requested data acquisition dialogs via a browser interface.
From a technical point of view, PAS-CAPA consists of three applications communicating interactively. These applications provide the core functions 'Corrective and Preventive Actions' (CAPA), 'Deviation Management' and 'Complaint Management'. For the proper mapping of the workflows within the individual modules the software offers a policy management concept based on access rights and roles. In combination with electronic signatures this system thus implements the standards of the current Good Manufacturing Practices (cGMP) and 21 CFR Part 11. PAS-CAPA is integrated online into Bayer HealthCare's ERP and MES environments.
Werum and BTS are now offering this newly developed system - either as component of Werum's MES product suite or as an individual, stand-alone software solution.
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 use Werum's product suite PAS X to run their manufacturing business. 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 230 people in their headquarters in Lueneburg, Northern Germany, the regional offices in Cologne and Hausach, Southern Germany, and the subsidiary in Towaco, New Jersey, USA.
Bayer Technology Services GmbH offers fully-integrated solutions along the life cycle of chemical/pharmaceutical plants - from development through engineering and construction to process optimization for existing plants. The Bayer subsidiary employs more than 2,100 experts worldwide at its headquarters in Leverkusen and other German locations, as well as in regional offices in Baytown, Texas, U.S.A.; Antwerp, Belgium; Mexico City, Mexico; and Shanghai, People's Republic of China. Including energy services for all Bayer sites in Germany (only the first six months of 2004), total sales for 2004 were 520 million euros.
Additional information about Bayer Technology Services: www.bayertechnology.com. More details about Werum: www.werum.com
Please contact:
Volker Mensing
Phone: +49 (0)4131 8900-689, Fax: +49 (0)4131 8900-20
E-Mail: mensing@werum.com
Dr. Arnold Rajathurai
Phone: +49 (0)214 30-241 44, Fax: +49 (0)214 30-962 41 44
E-Mail: arnold.rajathurai@bayertechnology.com
