• How Scary are the Device Safety Requirements in IEC 60601-1 Edition 3.1?

    13 October, 2015 Lisa Weeks, Marketing Communications, MasterControl

    Few things are more frightening to an overwhelmed and under-resourced medical device manufacturer than a change to a regulatory standard, particularly if it’s a big one. (Cue creepy music.) Such is the case with IEC 60601-1 Edition 3.1, the internationally recognized standard that addresses the general requirements for medical electrical equipment and devices. Amendment 1, which was introduced in 2012, contains more than 250 changes to the text of the standard, many of which significantly alter the standard’s meaning and/or intent. Scary, right? Even scarier, the FDA will begin enforcing the new requirements as early as August 2016. Yikes!

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  • Personal PDCA and How I Learned It

    15 October, 2015 Mark Reich, Chief Operations Officer, Lean Enterprise Institute

    In 23 years at Toyota, I had many assignments and different bosses, I managed many people, but a constant part of the culture was what I’ve come to call “personal PDCA” – a kind of mentored self-development cycle. When it comes to personal PDCA, my first problem solving experience during my first-ever assignment in Japan stands out for me.

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  • Trust is Not Just Nice, It’s the Key to Your Success

    19 October, 2015 Cindy Fazzi, Staff Writer

    Whether you’re a quality professional responsible for your system implementation or a CEO getting ready to launch a medical device startup, Stephen M.R. Covey believes there’s one thing you need to succeed—trust. “Trust is an economic driver, not merely a social virtue,” he said in his keynote address at the 2015 Masters Summit.

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  • FSMA: Get Inspection-Ready with These Best Practices

    20 October, 2015 Melanie J. Neumann, J.D., M.S. Executive Vice President The Acheson Group

    Although FDA immediately gained increased authority for records access upon the signing of the Food Safety Modernization Act (FSMA) in January 2011, some companies haven’t gotten the memo yet.

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  • 6 Traits You Should Develop to Become an Exceptional Quality Pro

    22 October, 2015 Cindy Fazzi, Editor, MasterControl Insider

    In a regulated company, quality professionals may be revered or dreaded or downright misunderstood. But there’s no denying their important role. As quality guru Joseph Juran said, all improvement happens project by project and in no other way. To paraphrase Juran, I would say a high-quality product or service happens step by step and process by process. Guess who’s responsible for making sure every step and every process is working effectively? You got that right—quality pros.

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  • Still Using Paper for Audits? Here’s Why You Need to Automate

    27 October, 2015 Steve Harrison, Product Manager, MasterControl

    A recent quality management system benchmark survey showed manual processes are still predominant over automated systems.[1] The results of the survey were compiled from over 100,000 professionals worldwide and the majority of the participants work in quality or regulatory positions across pharmaceutical, medical device and biotech industries.

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  • 10 Halloween Costumes that Will Inspire Quality Professionals to Communicate Even More Effectively with Their Executives

    28 October, 2015 Marci Crane, Marketing Communications, MasterControl

    Employment pundits say in today’s job market, it’s not enough to have skills and education. Today’s top employees must “dress for success.” What better time is there than the end of October to consider a bit of dress up?

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  • Streamlining CAPA Processes: Manual Systems vs. Automated Solutions

    29 October, 2015 by James Jardine, Marketing Communications, MasterControl

    The real challenge in managing corrective and preventive actions (CAPA) isn’t knowing whether or not you’re making the right decision or the wrong decision. It is understanding if you’re making smarter and better decisions. There are any number of ways a manufacturer can handle a quality event, but what is most crucial is that the organization is in the best possible position to effectively deal with that event.

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  • How Donald Trump and/or Hillary Clinton Would “CAPA the USA” if Elected in 2016

    3 November, 2015 Marci Crane, Marketing Communications, MasterControl

    Although a long list of candidates make up the list of “eligibles” for the 2016 Presidential election, it’s fairly apparent that the two most conspicuous candidates are, respectively, Democrat Hillary Clinton and Republican Donald Trump. These two candidates, though liked and disliked by various population pockets across the United States, have certainly managed to make names for themselves within their various areas of expertise.

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  • Training Effectiveness – A Quality by Design Approach

    5 November, 2015 Holly DeIaco-Smith, MS, HDS Consulting

    In the role of a consultant, you have the benefit of seeing what works well across your client base and their shared common pain points. Because of this perspective, I’m often invited onto a project to provide guidance on best practices and practical advice on how to avoid the common pain points.

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  • Why Every Business Needs to Make ISO Certification a Priority in 2015/2016

    10 November, 2015 Stuart Patch, Content Writer, Compass Assurance Services; info@compassassurance.com.au

    There are many benefits for organisations gaining certification and for those organisations that are currently certified, ensuring those benefits continue to be realised is very important. Below I look at the benefits of certification and also what are the benefits of keeping abreast of upcoming changes in standards.

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  • 6 Military Skills Highly Valuable to Manufacturers

    11 November, 2015 David R. Butcher, Marketing Communications, MasterControl

    Following years of high unemployment, the hiring outlook for service members transitioning into the civilian labor force is improving. The unemployment rate for veterans from all branches of the military is now just 3.9 percent, compared with 4.5 percent a year ago and a current national unemployment rate for all Americans of 5 percent, according to the U.S. Bureau of Labor Statistics last week.

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  • eTMF Management: Don’t Settle for a One-Trick Pony!

    12 November, 2015 Patricia Santos-Serrao, MasterControl's Market Segment Manager, Global Pharmaceutical, Blood & Biologics

    Organizations searching for an electronic trial master file (eTMF) solution are likely to stumble upon various vendors claiming to be the “industry leader in eTMF” or some variation of this statement. With so many vendors claiming to be leaders, what does that mean to be a leader in eTMF? Should it factor into my decision as I evaluate and choose a solution for my organization? The answers to that question may not be a clear cut as one may think.

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  • The Future of Medical Device Registries

    17 November, 2015 David R. Dills, Sr. Consultant, Regulatory & Compliance, Devices: NovusLife

    A registry is broadly defined as a collection of information about individuals, usually focused around a specific diagnosis, condition, or intervention. Individuals may provide information about themselves to a registry on a voluntary basis, either directly or through their physicians. A registry can be sponsored by a government agency, nonprofit organization, health care facility, or private company, and over time can provide researchers and other health care delivery stakeholders with first-hand information about patients, both individually and as a group, which can increase our understanding of that condition. This post places key emphasis on medical device registries and why this topic is becoming increasingly important with FDA and our device manufacturers.

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  • EDMS Evolution: Automated Document Management as a Differentiator

    1 October, 2015 James Jardine, Marketing Communications, MasterControl Inc.

    Thirty years ago, only the most elite, cutting-edge manufacturers had electronic document management systems. But 30 years ago we also had cassette players in our cars, memberships to Blockbuster video, and spare change for payphones. Over the past three decades, electronic document management systems (EDMS) have had the same “creative disruption” effect on manufacturers that streaming television services, online booksellers, tax software, and travel websites have had on the rest of the economic landscape.

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  • 9 Crazy Cousins You Probably Shouldn’t Invite to This Year’s Thanksgiving Dinner and 9 Reasons You Could Invite SCORM (Compliance) Instead

    19 November, 2015 Marci Crane, Localization Manager, MasterControl

    Thanksgiving in the USA is a wonderful time of year when we are reminded of everything that we have and how lucky we are to have it. We express our gratitude for what we have, where we live and those we love.

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  • Holistic CQMS: The Modern Model of Clinical Trial Management

    23 November, 2015 James Jardine, Marketing Communications, MasterControl Inc.

    The life science industry is experiencing a transformation in the clinical trial management paradigm. The timeworn clinical trial management system (CTMS) archetype is being increasingly supplanted by a more comprehensive and efficient clinical quality management system (CQMS) model.

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  • How ISO 9001: 2015 May Preview Upcoming ISO 13485 Changes

    25 November, 2015 David R. Butcher, Marketing Communications, MasterControl

    This fall, the International Organization for Standardization (ISO) published ISO 9001:2015, the updated quality management system (QMS) standard that now follows a new, higher-level structure and includes a number of other key changes that regulated companies have three years to meet.

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  • Inspection Readiness: Leveraging Inspection Focus Areas and Increasing the Transparency of Investigator Oversight

    1 December, 2015 Jessica Masarek, Quality Assurance Consultant | Independent Auditor Director, Muse Clinical

    Audits and inspections seem to be wrapped in a shroud of mystery, making folks stressed and unsure of exactly what is going to happen. What if I say the wrong thing? What if I don’t know the answer? What if I can’t provide what they are asking for? Realistically, all of these things will probably happen! That said, as long as you are honest, all will be well. Mistakes happen and no auditor or inspector is expecting perfection. We are expecting transparency. As an auditor, my goal is to confirm that the trial is run in a way that ensures the safety of subjects, protects their rights, and generates reliable data. Sponsors want to continue working with sites in which so much effort has been invested and will work to identify areas for improvement if deficiencies are noted. An inspector has a similar goal with respect to the assessment of trial conduct. So, how do we ensure that trials are run at the level of quality that regulators are looking for and that are truly inspection ready?

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  • The Mysterious "No Fault Found"

    3 December, 2015 Harish Jose Senior Quality Assurance Engineer

    As a quality engineer working in the medical device field, I find there is nothing more frustrating than a “no-fault-found” condition on a product complaint. The product is returned by the customer due to a problem while in use, and the manufacturer cannot replicate the problem. This is commonly referred to as no-fault-found (NFF). I could not find a definite rate on NFF for medical devices. However, I did find that for the avionics industry it is 40 percent to 60 percent of all the complaints.

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