GxP Lifeline

 

  • 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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  • 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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  • Multipurpose Tool vs. Best-of-Breed Platform: How to Tell the Difference

    15 September, 2015 Paul Sanderson, Solutions Consultants Group Lead

    When we invest in tools, we naturally want the most bang for our buck. Who hasn’t tried to use a screwdriver as a pry bar or a pair of pliers for loosening a bolt when a properly sized wrench would be more appropriate?

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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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  • OMG! The FDA Is Keeping Up With Kim Kardashian, Too

    28 August, 2015 Alex Butler, Product Manager, Life Science Applications (LS APPs), MasterControl

    Love her or hate her, reality-star Kim Kardashian knows how to get our attention. Whether she’s trying to break the Internet with risqué photos or agonizing over which Rolex to wear, people are watching. Kardashian boasts more than 34 million Twitter followers; 26, 074, 878 likes on her Facebook fan page; and 42 million Instagram followers. Forty-two million! That’s how many people may have seen her infamous July 19 Instagram post praising the morning sickness drug Diclegis® that landed her and drug maker Duchesnay in hot water with the FDA. “Kim Kardashian’s greed finally got the better of her,” the author of one op-ed piece for the popular U.K. tabloid the Mirror gleefully exclaimed.1 I’m not so sure. Perhaps Kim Kardashian is smarter than we think.

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  • FDA Requests Public Input on Quality Metrics Guidance

    27 August, 2015 Oliver Wolf, Senior Product Manager, MasterControl

    In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) released the draft guidance “Request for Quality Metrics” and is now seeking public input by September 28, 2015 on a number of key points.

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  • Three Things I’ve Learned about Quality Professionals

    26 August, 2015 Jon Beckstrand, CEO, MasterControl Inc.

    Over the past 15 years, as the leader of an organization dedicated to improving the success of the quality profession, I have met hundreds of people throughout the world who have a unique mission: build greater quality into the things we use every day. I have often asked myself, what do all these people have in common? What makes someone choose to dedicate his or her career to improving quality? Who are these people who dedicate their lives to making sure that things are done right, that we don’t skip critical steps? Whether it’s making sure that you aren’t using yesterday’s version of a work instruction or that you are trained properly on changes crucial to the implementation of a corrective action, quality professionals are ever vigilant about maintaining quality standards and compliance.

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  • Infographic: FDA Inspections By The Numbers

    25 August, 2015 Tony Chen, CEO and Co-Founder of FDAzilla

    Up until recently, it has been difficult to get data on FDA inspections. Sure, the FDA publishes aggregate data every year, but what about the granular data on every inspection?

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  • Education And Corrective Actions: The Solid Foundation Of Food Safety Culture

    20 August, 2015 Sam Lewis, Associate Editor, Food Online

    There is no doubt about it; it is getting more and more difficult to be a successful food processor or manufacturer. The supply chain continues to grow and become more complex, food safety regulations across the globe are becoming increasingly stringent, consumer preferences are constantly evolving, and the food industry’s workforce seems to be continuously changing. All of these trials amplify the importance of managing risks, keeping the public safe, and maintaining consumer loyalty to your brand. So, what can you do to manage this incessantly-growing number of risks?

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