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With the markets and manufacturers becoming more global and competitive, not only are the pressures from the regulatory agencies increasing but the pressure of productivity and quality assurance are gaining importance. While today not only production is more globally oriented it is also the supplies that come from various international sources. Looking back into the recent economic past is necessary to understand today’s requirements when it comes to quality and documentation needs. Management these days are challenged to ensure overall compliance, manage operational risks and make sure that positive customer experience is transported into the global markets. Nonconformance problems in manufacturing have to be identified and eliminated. Above all is the cost of quality, that needs to be reduced to stay competitive.

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