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
This text was translated automatically.
