• 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • Risk Takes Center Stage in ISO 9001: 2015

    8 October, 2015 Lisa Weeks, Marketing Communications, MasterControl

    If you’re unfamiliar with the concept of risk, or your exposure to it has been limited, now is the time to get comfortable with all aspects of risk as it relates to the quality management system. Why? Because the latest edition of the standard makes risk management, which has always been implicit, explicit. In other words, it’s no longer optional; it’s a must.

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  • Quality Audit: The Direct Route to Continuous Improvement

    6 October, 2015 Beth Pedersen, Marketing Communications Specialist, MasterControl

    If your organization is GxP-regulated or ISO-certified, you are no stranger to the burdens of audit. The regulations and standards that govern your operations change often, and yet you must somehow manage to understand and comply with them – and be able to clearly demonstrate your compliance – at all times.

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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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  • MFG DAY 2015: U.S. Manufacturing at a Glance

    30 September, 2015 David R. Butcher, Marketing Communications, MasterControl

    In recent years, a swing in public perception has led to widely held misconceptions of United States manufacturing – that modern manufacturing environments are dark, dangerous and antiquated factories designed for low-skilled workers.

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  • What Do You Do? A Short and a Long Answer

    29 September, 2015 Jon Beckstrand, MasterControl CEO

    I was recently asked point-blank: What does MasterControl do? I was being interviewed for a medical device publication’s podcast, so the question was expected. Still, it forced me to mull over the company’s mission and accomplishments in the past 13 years under my leadership.

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  • Secrets of Form Design: Forms Can Be Fantastic

    24 September, 2015 Nye Joell Hardy, Food Safety Technical and Regulatory Writer

    Okay, you’re ready. You have your policy. You have a great plan. You have the SOPs. Now all you need to do is implement it!

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  • Preparing for the Impending Medical Device Regulation

    23 September, 2016 Linda Chatwin Esq, RACUL LLC, Senior Customer Solutions Consultant

    It’s coming – and at this point, nothing will stop it. The Medical Device Directive (MDD) is being recast to a regulation – the Medical Device Regulation (MDR). It has been over four years in the making and the EU countries have spent many hours (actually over four years) working to agree on its Consolidated Negotiated Text.

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  • What Is a Food Safety Plan and What Is It Doing on My Table?

    22 September, 2015 W. Lynn Hodges, HACCP Consulting Group, LLC

    Whenever you go out to eat with your family, co-workers, or friends, you may be unaware that many of the restaurants (food service establishments) and retail food stores have some type of food safety plan in place. Most of the chain restaurants have sophisticated food safety systems designed and implemented for their daily operations and as well as many of the larger, more established restaurants and retail food stores. The U.S. Food and Drug Administration encourages these retail food operations to implement food safety systems and use them throughout the everyday activities of the operations.

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  • Hacking GMPs: Deliberate Attacks or Accidental Workarounds?

    17 September, 2015 Vivian Bringslimark, President & Owner, HPIS Consulting, Inc.

    The subtitle tells it all. Most employees don’t come to work with the intention to cause harm, fail or make mistakes intentionally. Yet mistakes, errors, and failures happen. According to Sidney Dekker, author of The Field Guide to Understanding Human Error, “mismatches between written guidance and operational practice always exist”. I’s due to “the amount of increasingly tight constraints of procedures” (p.8). There have been some occasions where following a procedure could have caused a deviation if it weren’t for an astute technician who questioned the “GMP” rule. Talk about a GMP dilemma, “always follow the SOP” but don’t create a deviation either. Alas, we have a classic example of a white hat hacker.

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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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  • Inspecting Clinical Trials - MHRA on the Trial Master File

    9 September, 2015 Gail Francis, Expert Inspector, GCPMHRA

    The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed. This blog highlights some of the issues which have been experienced by sponsors and inspectors attempting to manage and review the large amounts of documentation that exist in support of a trial.

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  • Building Forms for Regulated Environments: Top 10 Best Practices

    8 September, 2015 Cindy Fazzi, Editor, MasterControl Insider

    Whether you’re applying for a job or a loan, or registering for a conference or membership in some organization, there’s one thing you must do—fill out a form. We can’t live without forms. In regulated environments, they are even more crucial because they can affect regulatory compliance.

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  • The CAPA Detective

    3 September, 2015 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    Every industry has its detectives. Mechanics and journalists hunt for leaks. Software testers and security experts look for bugs. Meteorologists, defense strategists, and forensic accountants all look for trouble brewing off shore. The level of intrigue may vary.

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  • The Patient is Missing

    1 September, 2015 Amy Musolino, Program Director, New Service Development, Fisher Clinical Services

    Recently, I had the opportunity to attend a presentation by Patricia Larrabee, CEO and founder of Rochester Clinical Research. While there, I couldn’t help reflecting on the truly significant contribution that patients play in the success of clinical research. Furthermore, what a burden we often inadvertently place on them as well as our investigator sites.

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