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Showing items tagged as Case for Quality

  • Quality 4.0: Harnessing Technology to Enhance Traditional Quality Methods

    21 November, 2017 by Mike Rigert, Content Marketing Specialist, MasterControl

    Industries and manufacturers are increasingly approaching the challenge of digital transformation, some with caution, some with great anticipation, yet perhaps still others with unease. However, the message in a recent analyst report “Quality 4.0: Get Educated Get Involved, and Build a Successful Strategy” is clear—transform your company’s operations and efforts digitally or risk digital disruption. Forty percent of companies have already started a digital transformation initiative while another 17 percent kicked off initiatives in 2017, according to the report, which was co-sponsored by LNS Research and MasterControl.

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  • FDA Guidance Answers Questions Regarding Data Integrity

    23 March, 2017 by David Jensen

    An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “

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  • Top 7 Takeaways from AdvaMed 2016

    26 October, 2016 Lisa Weeks, Marketing Communications Specialist MasterControl

    Last week, I attended AdvaMed 2016, the leading medtech conference in North America. This year’s conference was the biggest yet, with more than 2,650 medtech professionals descending on Minneapolis for three days (October 17-19) of educational sessions, lively panel discussions and inspiring patient stories. As the birthplace of the modern medical device, and home to nearly 1,000 health technology companies, Minneapolis was a suitable host location to celebrate the tenth anniversary of the confe

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  • Is Compliance an Obstacle to Quality?

    15 September, 2016 Daniel Matlis, Founder and President, Axendi

    Can you distribute poor quality products while complying with regulatory requirements? Sure, after all, you can conduct a recall of poor quality products in compliance with all applicable regulations.

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  • The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients

    18 February, 2016 Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., and Melinda K. Plaisier, M.S.W., Food and Drug Administration

    Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review and analysis of that data, which in turn can promote the practice and culture of quality within firms.

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