Product category:
QC and QA systems
News Release from: Werum Software and Systems | Subject: Bayer HealthCare
Edited by the Processingtalk Editorial
Team on 17 November 2005
Bayer HealthCare AG Introduce Werum IT
System
Werum Software and Systems has implemented a web based software system to enhance quality assurance at the Bayer HealthCare AG, in full compliance with GMP requirements
Werum Software and 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
This article was originally published on Processingtalk on 14 Sep 2006 at 8.00am (UK)
Related stories
Werum provides PAS-X MES for production at Bayer
Bayer HealthCare is now using Werum PAS-X software to run its parenteral drug manufacturing at its Leverkusen, Germany site, further expanding the domain of the Werum MES product suite at Bayer
Active ingredient production at Bayer uses PAS-X
A third active ingredient plant has been furnished with a PAS-X system by Werum Software and Systems at the Bayer HealthCare production site of Wuppertal-Elberfeld in Germany
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 ERP and MES environments.
Werum and BTS are now offering this newly developed system - either as component of the Werum MES product suite or as an individual, stand-alone software solution.
• Werum Software and Systems: contact details and other news
• Email this article to a colleague
• Register for the free Processingtalk email newsletter
• Processingtalk Home Page
Search the Pro-Talk network of sites
