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| News PAS-X Production Management |
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| Werum Software & Systems expands its product spectrum
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Software module PAS-CAPA complements pharma and biotech portfolio
New software suite PAS-X CT for clinical trial supplies management
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Werum Software & Systems, a leading supplier of Manufacturing Execution Systems (MES) for pharmaceutical and biopharmaceutical production, will present its expanded product spectrum at the ACHEMA. Werum has further enhanced its proven MES product suites PAS-X PHARMA and
PAS-X BIOTECH with the software module PAS-CAPA for quality assurance. A completely new development is the software suite PAS-X CT for manufacturing clinical trial supplies.
PAS-CAPA for the management of deviations and complaints
The web-based software system PAS-CAPA is designed to continuously support improvement of product and process quality in pharmaceutical and biopharmaceutical production.
The software covers the core function groups Deviation Management, Complaint Management and Corrective and Preventive Actions. PAS-CAPA provides efficient tools for collecting, assessing and documenting deviations from standards, revisions, customer complaints, investigational findings, change requests and ensuing corrective and preventive actions in a manner compliant with regulatory requirements. PAS-CAPA is characterized by its simple and intuitive configurability and usability.
Werum and Bayer Technology Services (BTS) cooperated closely during the technical development and the installation of the reference implementation at Bayer HealthCare, and are now offering the newly developed system, either as a component of Werum's pharma and biotech product suite, or as an individual, stand-alone software solution.
PAS-X CT for clinical trial supply management
Werum's new software product line PAS-X CT has been specially designed to manage and handle the clinical trial supplies for clinical studies.
Compared with common systems currently on the market, a significant innovation is the development of a structured and intuitive user interface that facilitates cooperation between all parties involved in producing and delivering patient kits. PAS-X CT has been optimized to achieve following main objectives: Providing ease of definition and high flexibility in the planning phase of clinical trials, achieving regulatory requirements during all phases of production and assuring operational excellence in packaging and labeling operations.
Whilst Werum's many years of experience and expertise as a software supplier for the pharmaceutical industry facilitated the successful development of PAS-X CT, the researching pharmaceuticals manufacturer ALTANA Pharma contributed additional practical knowledge in the optimization of functions and user guidance of the new development in their capacity as a first reference customer.
Visit Werum at the ACHEMA: Hall 10.2, stand B46-D48
Invitation:
Werum Press Breakfast at the ACHEMA
on Tuesday, 16 May 2006, starting at 09:30 a.m.
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