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ValTec solves tasks of quality on highest level

ValTec löst Qualitätsaufgaben auf höchstem Niveau
ValTec löst Qualitätsaufgaben auf höchstem Niveau
The ValTec GmbH is an expanding enterprise and works national as international as Dienstleister in the range qualification, validating and quality management for the pharmaceutical and chemical industry. Since newest the enterprise offers, with seat in Neuhausen at the case of Rhine (Switzerland), also within the range its achievements to the medical technology. Production processes in the pharmaceutical, chemical and also medicine-technical industry become increasing ever more complex. The requirements of the legislators on national and international level rise. Controlled and optimized processes as well as a conclusive quality and project management are located in the focus of the manufacturers and suppliers. Experienced engineers of the ValTec GmbH are in the best way prepared for it. They know national like international defaults and help during the establishment and optimization of processes and procedures.Special emphasis is here on the GMP fair qualification and validating. Pure space concepts and processing units advisory actively is the Dienstleister likewise with the production of pure space concepts and the acquisition of new processing units. In order to keep valid requirements and specifications, Design, interpretation, installation and function are examined. Necessary measures for the qualification and validating are so substantially more effective and the cost saving thereby higher. "enterprises often know successful co-operation very exactly, what must be considered during the qualification process", thus Claudia Pachl, engineer with ValTec, "it is missing however personnel and temporal resources this process to implement. We support our customers when planning, execution and documentation of their projects."in co-operation with persons made of enterprise, technology and quality assurance of the enterprises the ValTec coworkers compile GMP fair solutions. A project plan is provided, defined requirements and conversion to resting and product requirement specifications and accomplished a risk analysis according to recognized methods (e.g. FMEA, HACCP, HAZOP, fault tree, fish fishbone diagram). Test plans follow and report for the execution of the qualification and validating. With a recapitulatory report the project is locked and a GMP fair documentation is handed over. So far necessarily, appropriate sample collecting mains are provided and internal operational sequence in instructions for procedure (SOPs) are described. The training of the personnel rounds the power spectrum off. Thus a continuous quality is ensured in excellent form. Of course also particular of these achievements can be taken up.Enterprise prepares audit the ValTec GmbH for lining up audits by authorities, is accompanying suppliers and customers and thereby actively. Also internal audits are made by that Swiss company, existing structures and conditions are analyzed. The existing standards and defaults area for the interpretation and conversion leave quality management for medicine products within the range of the medical technology. Here a competent consultation becomes the more important. ValTec supported with the structure and the extension from quality management systems to DIN EN ISO 13485 or 21 CFR §820. requirements from the DIN EN ISO 14971 are converted in the risk management. Projection/lead by knowledge thanks of professional experience of several years the coworkers of ValTec can fall back, predominantly engeneering graduates (FH) the Pharmatechnik, to an extensive specialized knowledge.Regular advanced training, the participation in lectures, meetings and fairs, round the qualification profile off. By honorary participation in the association of German engineers (VDI) clean-room technology a landspreading knowledge exchange with specialists takes place within the range. Thus a procedure on the most current state of the art is ordered to the customer. Due to short training periods costs can be saved clearly. Many considerable enterprises of the middle class as well as big customer from Southern Germany and Switzerland are extremely content with the quality of the furnished achievements. Plus service particularly customer-oriented shows up the ValTec GmbH as it their clients advises and effectively during the conversion of compiled concepts and tasks participates. Claudia Pachl: "we offer besides a comprehensive service. The customers can be cared for at any time also at short notice.Our team reacts very flexibly to their desires, with continuously high-quality quality. We help small ones, medium-size and large-scale enterprises to develop and extend quality management systems. Just as existing systems and process are optimized and we are supporting actively, if it concerns the planning and execution of new projects." (railways Public relation fire, postal address: Gomaringer STR. 23, 70597 Stuttgart, telephone: 0711-44 00 864, fax: 0711-44 00 867, brandesign@gmx.de) contact ValTec GmbH central road 100 CH-8212 Neuhausen at the case of Rhine Switzerland telephone: +41 (0)77 429 31 11 fax: +41 (0)52 675 00 01 E-Mail: info@valtec gmbh.com InterNet: www.valtec gmbh.com

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Dokument:
ValTec löst Qualitätsaufgaben auf höchstem Niveau

Further information


VALTEC_Pantone_2747_rgb_web_200px
ValTec GmbH
Zentralstrasse 100
8212 Neuhausen
Switzerland
Phone: +49 173 6983802
Fax: +41 52 6750001
email: claudia.pachl@valtec-gmbh.com
Internet: http://www.valtec-gmbh.com


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