• INFOGRAPHIC: Closed-Loop Quality Management and the Cost of Inaction

    11 September, 2014 David R. Butcher, Marketing Communications, MasterControl

    In today’s global manufacturing environment, continuing to rely on outdated, siloed quality management technology comes at a cost that many regulated companies simply cannot afford, new research indicates. That is why leading manufacturers are taking quality management further, leveraging EQMS to develop closed-loop quality processes that track quality throughout the value chain.

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  • Current Issues in Medical Device Risk Management

    29 July, 2014 by Edwin Bills, RAC Consultant

    Medical devices have been developed with some requirements for product safety since the implementation of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act.  Initially FDA required manufacturers to submit information related to safety as part of the 510(k) premarket notification process, providing comparative data on predicate devices versus the device under consideration.  In the more rigorous Premarket Approval (PMA) process, more detailed safety inform

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  • Quality Beliefs Determine Behavior

    29 April, 2014 by Craig Gygi, Executive Vice President Operations, MasterControl Inc.

    A few years back, I helped an international holding company assess the operations of their portfolio of companies. They wanted to know things like, “How Lean is the operation at each company?” “How far along is each company in its Six Sigma improvement journey?” And “What are the common opportunities and strengths we can build upon?” I visited company sites, reviewed operation activities, collected data, and interviewed executives and staff. I found that in many ways, the foundation for excellence in operations can be boiled down to a single, simple question: “How do you define quality?”

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  • Four Team Members to Include When Building Your Software Implementation Dream Team (and Two to Avoid)

    11 March, 2014 by Stephanie Jones, Professional Services Consultant, MasterControl Inc.

    According to a study by Gartner Research, nearly four in ten major software purchases end up as “shelfware,” i.e., software that is purchased and never implemented or only marginally configured and/or deployed. Why? Often, it is because of the application itself or the perceived unresponsiveness of the software vendor’s implementation consultants. Rather than compromise efficiency, or redesign proven processes which took years to develop and implement, an organization will opt to delay or abando

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  • More Helpful Quality Event Management Tips from MasterControl CAPA Presentation

    5 March, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    A previous post to this blog covered some of the highlights of a recorded MasterControl webinar that discusses best practices for corrective and preventive action (CAPA) systems. The free recording is presented by quality expert Ken Peterson, a prominent consultant who has decades of experience with risk management, customer service, and CAPA systems. Peterson has devoted his quality expertise to a long list of successful companies such as Pfizer, Abbott Laboratories, Kodak, and IBM.

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  • Be SMART: 5 Critical Factors in CAPA

    4 March, 2014 by Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    It’s not enough to come up with a corrective action for a quality event. It’s critical to have the right action that actually fixes the problem and prevents it from recurring.

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  • Digging up Root Cause

    23 January, 2014 Robyn Barnes, Public Relations, MasterControl Inc.

    Dan O’Leary, president at Ombu Enterprises, LLC, started an interesting discussion on LinkedIn’s Corrective and Preventive Action Group. He was wondering where the term “root cause” came from.

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  • MasterControl Electronic Quality Management Software Solutions Benefit a Wide Range of Industries

    4 November, 2013 James Jardine

    For more than two decades MasterControl software has made it possible for hundreds of companies in an extensive array of industries across the globe to improve quality processes and get products to market more quickly. Companies doing business in regulatory environments in particular use MasterControl solutions to ensure sustained compliance and stay ahead of competitors.

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  • Developing a QMS: Should You Buy or Build?

    11 December, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    When it comes to a quality management system, should you buy or build? Many regulated companies face this dilemma. Perhaps these companies are small startups without a QMS, or maybe they are established but they want to improve their existing systems.

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