It is imperative for Life Sciences companies to look at improving the performance of Quality Management Systems especially in a time of economic pressures for reducing cost and maintaining a competitive advantage.

Goals

Achieve the optimal level of quality by balancing the expectations of customers and regulators while achieving a competitive edge and increasing shareholder value.

Solutions

Successfully achieving an optimum level of quality requires a top down, proactive approach. One of the first steps requires the establishment of a roadmap to optimize the quality management system. This roadmap will reduce cost and provide a competitive advantage for the company.  Establishing a prioritization of improvements that provides a quick return on investments while continuing to move toward an optimum state for the long term is essential for success.

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Assessments for Compliance and Optimization

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Develop quality improvement roadmaps

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Quality management system assessments to identify systemic issues that can cause risk of non-routine quality events to occur.

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Assess the processes for opportunities for optimization

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Help with 483 observations, warning letters, consent decree

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Quality systems remediation activities

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Assessing technology for solutions to move from paper based to digital solutions for quality system controls and processes.

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Providing resources to handle the scale up and down of resources for on-going day to day projects.