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Showing items tagged as Software

  • CFDA Medical Device Software Regulation Undergoes Major Revision

    14 April, 2016 Beth Pedersen, Marketing Communications, MasterControl

    With so many international regulatory bodies governing different countries and industries, it can be difficult for manufacturers to stay abreast of all of the changing regulatory environments and requirements across the globe. On August 5, 2015, China Food and Drug Administration (CFDA) released its “Principle of technical review of medical device software” (2015 Order No. 50). The principle, which is only available in Chinese, signals a major change for documentation requirements for stand-alone software or software components developed by medical device manufacturers or their development partners.

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  • 6 Steps to Simplify Software Validation

    10 September, 2015 Kevin Ballard, Director of Software Validation, MasterControl

    Validation is one of the most time-consuming and resource-intensive activities when implementing eQMS software in a regulated environment, often delaying implementation and an organization’s ability to go live with new software.

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  • 3 Keys to Driving Collaborative Growth in Life Sciences

    26 March, 2015 James Jardine, MasterControl

    A recent study by LNS Research shows that life sciences companies are facing an unprecedented demand for better and safer products. Results from LNS Research’s surveys of industry executives indicate the pressures life science organizations are facing and the new technologies and processes they are employing to meet rising needs.

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  • Closed-Loop Quality Management: Connecting the Value Chain

    24 March, 2015 James Jardine, Marketing Communication, MasterControl

    An increasing number of leading organizations are learning that quality management must extend far beyond the manufacturing environment, according to a recent eBook co-sponsored by LNS Research and MasterControl. The research collected in the eBook indicates that market leaders are beginning to implement a closed-loop approach to quality that bi-directionally unites people, processes, and data across the value chain. This approach connects quality from design and procurement stages all the way through manufacturing and service. Other findings in the book show that Enterprise Quality Management Software (EQMS) is vital to the establishment of an effective closed-loop system that can help a manufacturer better control costs, compliance, and risk.

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  • Version 11 of MasterControl Features More New Enhancements than Any Previous Release

    7 August, 2014 by James Jardine, Marketing Communications, MasterControl

    The recently released version 11 of MasterControl software dramatically accelerates customers’ ability to deliver life-changing products to those who need them most.

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  • MasterControl Demonstrating Quality Management Software at MD&M East and DIA

    12 June, 2014 by Robyn Barnes, Marketing Communications, MasterControl Inc.

    June is the month for weddings and trade shows. Though we're not celebrating any nuptials, you’ll find MasterControl at MD&M East this week and at DIA the week of June 15.

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