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Moreover, being able to work in team reinforces the global quality, reduces the errors, increases the consistency and the global knowledge.
This is widely proven that this way to operate brings also innovation and provides benefits not available before. Preventing rather than repairing could be one motto fitting here. Preventing means discussing all the "black points" before acting and consequently making efficiency gains in a compliant manner while saving substantial costs and time to market. Those are some of our tasks and our contribution as partner for the regulated industries.
We use a compliant process based approach, which is a precondition for being a recognized partner to the highly regulated process manufacturers. Our corporate validation master plan is implemented and demonstrates the compliance of our global offering to the most strigent laws, rules and recommendations. This is one of the reason why our company is recognized as a worldwide and advanced leader in process instrumentation for pharmaceutical and biotech's.
The pharmaceutical companies are nowadays global. Their partners must also be global, as we are.
Critical measuring points ( as described in the ISPE-GAMP Good Practice Guide - January 2002 ) represent the process parameters. The measuring instruments used but also the relevant services and documents ( DQ, IQ, OQ, PQ ) have to be in accordance with the guidelines described in the Good Practice Guide. The persons involved have to be trained. This means in practice that our sales engineers, project leaders, Industry specialists, Calibration Engineers, Documentation managers muste be strongly trained on the GxP's ( certificates available ).
The latest fieldbus digital transmission technologies ( e.g. profibus ) improves substantially the integrity of the measurement, increases its performance while simplifying the documentation. Operating costs can be drastically reduced. Moreover the predictive functions and capabilities like the monitoring tasks are easy to implement.
Lifecycle and traceability of the commercial and technical data of instruments can be achieved with W@M ( Web Asset Management ) which is an enterprise portal available on Internet enabling a real time access to all the relevant data for the instrument follow up. From the selection to the removal of the process through purchasing, installation, commissioning and operational phase you may link to our databases to access to any type of documentation for the instruments and tools.
The comprehension of the needs of the pharmaceutical manufacturers, the risks assessment, the relationship, the shared decision making, the reliability of the deliverables, the expertise and the global fit create the best possible partnership and trust atmosphere.
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