Showing items tagged as Quality

  • MasterControl Says “Go Live” to Localized Websites

    6 November, 2014 Jason Clegg, Director of Marketing, MasterControl

    At its core, website translation is a process that allows everyone across the globe to access the same opportunities and/or products in their own languages. This is especially important to companies like MasterControl that are expanding in to international markets.

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  • FDA vs. EU Inspections: Similarities & Differences

    14 October, 2014 Marie E. Dorat, CQA, CAA IPRF, LLC – RA/QA Consulting & International Product Registration EU-FDA Joint Initiative

    The U S Food and Drug Administration (FDA) and European Medicines Agency (EMA) Good Clinical Practice (GCP) initiative started a joint inspection program in September 2009.  This inspection program targets investigator sites, sponsors, and contract research organizations (CROs) in either the US or the European Union (EU).

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  • 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    In today’s global manufacturing environment, continuing to rely on outdated, siloed quality management technology comes at a cost that many regulated companies simply cannot afford, new research indicates.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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  • Medical Device Development: Thinking Globally, Acting Locally

    14 August, 2014 by Timothy Blair, Director, Global Business Development, NAMSA and Seth J. Goldenberg, PhD, Senior Principal Scientist, NAMSA

    The global healthcare and healthcare service market will maintain steady growth due in large part to an aging population that is living longer and to improved healthcare services in emerging markets that include China, Brazil, India, Japan, Israel, and South Korea, among others. It is interesting to note that countertrends seem to be developing in the medical device space; for example, hospital utilization of medical devices has slowed significantly, reimbursements continue to tighten, and there was a first-time global decrease (5%) in US premarket approvals (PMAs) in 2012, a trend that continued into 2013. There were also fluctuations in investor healthcare spending across 2012, drops in mergers & acquisitions deal value and deal counts, and a device tax that is adding to the squeeze.

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  • Certification: Is It Worth the Hassle?

    12 August, 2014 by Lisa Weeks, Marketing Communications, MasterControl

    In the life sciences and other regulated industries, obtaining certification in a range of international standards has become a necessity for companies hoping to access and compete in today’s global marketplace. Whether your organization is a laboratory, medical device manufacturer, or automobile maker, becoming certified by an impartial third-party accreditation body assures potential customers that you value quality and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages. But certification can be a long and trying process.

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  • Questions All Auditors Should Ask: The Use and Misuse of Audit Checklists

    31 July, 2014 by Laurie Meehan, Polaris Compliance Consultants, Inc.

    There’s nothing wrong with using a good checklist, as long as you remember that there will always be something wrong with your checklist. It is simply not possible to develop a checklist that will get to the core of every problem, that will cover every scenario, or that will ever be any reasonable substitute for that all important question: “Why?” So how can you develop the best checklists possible and avoid relying on them too heavily?

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  • Creating a Global Regulatory Plan

    24 June, 2014 by Cheryl Wagoner, Wagoner Consulting LLC

    Having and maintaining strong global regulatory strategy and plans can help your business not only stay in compliance but can be an integral part of corporate market growth strategies. How many of us have jumped into a new market before fully understanding the regulatory requirements and the potential impact of those requirements? If you have, you are not alone. Mapping the requirements as part of your strategic planning may help you identify a great new market or help you avoid a costly mistake.

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  • 3 Common Cybersecurity Mistakes in Pharma (and How to Avoid Them)

    17 June, 2014 by Jim King, Senior VP of Technical Support & Infrastructure, MasterControl Inc.

    Due to the ever-rising position of information as a valuable commodity, organizations must take steps to protect their data. For pharma and life sciences companies, the question is not if their digital data will be compromised, but when. Here are three common security mistakes made by enterprises and ways to avoid those mistakes by focusing on employee behavior.

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  • How Can You Measure the Return on Your QMS Investment?

    29 May, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    Every provider of electronic quality management systems claims its product will give you a significant return on your investment. But how can this ROI be truly measured? To find out, MasterControl recently surveyed customers to learn more about their levels of waste and efficiency before and after implementation of MasterControl's quality management system (QMS). Some of the results of the survey are compiled here in an informative infographic.

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  • Ruined by Best Efforts

    22 May, 2014 by Craig Gygi, Executive Vice President, MasterControl Inc.

    When W. Edwards Deming famously said, “We are being ruined by ‘best efforts,’” he was conveying the idea that simply striving to improve—even with laudable effort—can actually have the opposite outcome. How can this be? How could good intentions and diligent work ever possibly sabotage us? Well, they do all the time.

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  • Strategies for Addressing the Top 3 Quality Pains in a Regulated Environment

    8 May, 2014 by Paul Sanderson Lead, Solutions Consultants Group, MasterControl Inc.

    In the past 10 years that I’ve been working with highly regulated companies, I’ve seen many organizations find out the hard way that quality does not occur by accident. Quality requires good planning, design, and execution.

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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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  • Demystifying FDA/CDRH Appeals Process

    3 April, 2014 by David Lim, President and Principal of Regulatory Doctor and Yoonhee Beatty, Regulatory Affairs Associate, Bard Access Systems, Inc.

    We present a summary of available options to request additional review of FDA decisions or actions, including how to choose an option when a stakeholder has reasonable grounds to disagree with FDA/CDRH’s decision. It is worthwhile to note and get familiarized with the available options. However, it is recommended the stakeholder try to avoid having such situations in the first place.

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  • Food Safety is a Matter of Degree

    7 March, 2014 by Robyn Barnes, Public Relations Specialist, MasterControl Inc.

    Global Food Safety Conference 2014 kicked off recently in Anaheim, California with a record-breaking attendance. It seems that everyone is concerned about the condition of the food they eat, if they have it to eat.

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  • Quality Event Management: Free Recorded Webinar Shows How a Closed-loop Methodology Can Improve CAPA Systems

    27 February, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    Quality guru Ken Peterson has dedicated his career to helping organizations like Abbott Laboratories, Kodak, and IBM devise better quality management solutions that allow them to maximize efficiency and resolve problems faster. In the first of a three-part series of complimentary webinars available from MasterControl, Peterson breaks down quality management into three distinct segments: quality events, issue review, and corrective and preventive actions (CAPA). You can view the free webinar in its entirety here. No registration is required to access the recorded presentation—just click and play!

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  • Collaboration is More Than Just a Buzzword in Regulated Environments

    10 February, 2014 Marty Jackson, Professional Services Consultant, MasterControl Inc.

    Each year, there seems to be a buzzword that pervades the business community. This year, I recall hearing the word “collaboration” more than ever. For most organizations, the word is synonymous with “participate.”

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  • MasterControl's Murray & Knauer Guest Speakers at MD&M West

    5 February, 2014 Robyn Barnes, Public Relations, MasterControl Inc.

    If you’re working in the medical device industry, chances are you’ll be heading for MD&M West in Anaheim next week. MD&M West is the world’s largest medical OEM event.

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  • Where Are You in Your Quality Management Maturity?

    31 January, 2014 Robyn Barnes, Public Relations Specialist, MasterControl Inc.

    We’ve all heard about quality management journeys or trips down the quality lane. I heard someone recently equate quality to following the yellow brick road. Quality similes are usually about pathways but this week, I read a new description.

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  • How Dole Uses Technology and Proactive Food Safety Program To Save Time, Money

    27 January, 2014 Nye Joell Hardy, Senior Food Safety Manager, Dole Fresh Vegetables

    This article is based on a presentation the author gave at the FoodSafetyTech Conference on May 17, 2013 in Chicago.

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  • An Argument for Effective Quality Management Systems

    31 December, 2013 Kamaal Anas, Vice President Regulatory Affairs, Wright Medical Technology

    All too often, quality management systems are seen as a cost of doing business – a requirement of regulators (e.g., 21 CFR 820), customers (e.g., ISO 9001:2008) or overbearing parent companies – rather than as a tool for management to effectively manage their organizations. However, quality management systems that are effectively designed, implemented, utilized and continuously improved upon provide management with quality information, delivered in a timely fashion, which facilitate data-driven decision making. Designing and implementing a quality management system that provides the appropriate information for management to make educated decisions requires careful thought and detailed planning. Once accomplished, management will have the tools to effectively allocate resources to risk-prone areas and reduce the cost of poor quality.

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