GxP Lifeline

 

  • CFDA Medical Device Software Regulation Undergoes Major Revision

    14 April, 2016 Beth Pedersen, Marketing Communications, MasterControl

    With so many international regulatory bodies governing different countries and industries, it can be difficult for manufacturers to stay abreast of all of the changing regulatory environments and requirements across the globe. On August 5, 2015, China Food and Drug Administration (CFDA) released its “Principle of technical review of medical device software” (2015 Order No. 50). The principle, which is only available in Chinese, signals a major change for documentation requirements for stand-alone software or software components developed by medical device manufacturers or their development partners.

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  • Med Device: How to Address the Documentation Burden of Design Control

    12 April, 2016 Matthew M. Lowe, Executive Vice President, MasterControl

    Design control issues represent a key challenge for many medical device firms. This is the reason why in 1996, the U.S. Food and Drug Administration (FDA) added design control principles to 21 CFR Part 820 and required rigorous documentation to demonstrate design control.

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  • Income Tax Myths and Document Control Systems

    5 April, 2016 Robyn Barnes, Marketing Communications, MasterControl

    I’ve been reading Steve Berry’s novel, “The Patriot Threat.” The crux of the book is that the 16th Amendment to the Constitution, the one that requires Americans to pay income tax, may be illegal. The story goes that some of the states may have never ratified the Amendment, and some may have ratified a document that didn’t have the same wording as others. (I won’t spoil the mystery by telling you what transpires.)

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  • Compliance, Innovation and GMPs at the 32nd SQA Annual Meeting & Quality College

    4 April, 2016 Robyn Barnes, Marketing Communications, MasterControl

    If you’re not cultivating a culture of quality at your workplace, what are you doing to improve compliance, innovation and good manufacturing practices (GMPs)?

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  • Six Signs of Potential FSMA Fakes

    31 March, 2016 Nye Joell Hardy, Food Safety Technical and Regulatory Writer

    Since companies that grow or process fresh produce are now required to follow the Food Safety Modernization Act of 2011, it should be no surprise that there are people out there trying to make a buck off of all that confusion and desperation. Some of these companies are honestly putting their best food forward in trying to meet your needs, but there are others you should worry about, especially if they say any of these six things:

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  • ISO 9001:2015 - A Powerful Addition to Your Professional Tool Kit

    29 March, 2016 Greg Peckford Founder, Quality Career Advancement

    There are over one million organizations in over 170 countries registered to ISO 9001. That alone is a pretty impressive statistic claimed by www.iso.org. But what this stat is missing are the countless other companies worldwide that have adopted the ISO 9001 standard as a blueprint for the development and implementation of their quality management systems without becoming formally certified.

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  • Quality Management has Moved On!

    24 March, 2016 Andrew Foy Owner, Foy Certification Ltd.

    Quality assurance was originally conceived to document a set of procedures aimed at ensuring that quality standards and processes were adhered to by a business; but has now moved beyond the tick box concept and can play an integral part in improving business performance.

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  • Stop Asking Why

    22 March, 2016 Harish Jose, Senior Quality Engineer, ASQ CRE, ASQ CQE, ASQ CSSBB, ASQ CBA

    My friend was doing data analysis of ERP transactions, and he noticed that the material handler was creating transactions in two different programs for dock-to-stock components. This process created double entries and did not seem to add value. He asked the question “why” and the material handler reported that she was doing it because it was the way she was trained, and because it was the way they had always done it.

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  • The SCIO Concept: How to Conduct Cost-Effective Clinical Trials

    17 March, 2016 Dr. Candida Fratazzi, M.D., Founder/CEOBBCR Consulting, (Boston Biotech Clinical Research)

    The average cost of developing a new drug is notoriously high. In a study conducted through the Tufts Center for the Study of Drug Development in 2014, Dr. Henry G. Grabowski and Dr. Ronald W. Hansen concluded, “The estimated average pre-tax industry cost per new prescription drug approval (inclusive of failures and capital costs) is 2,558 billion.” The story does not end here. For the past 20 years, the cost of new drug development has risen at a rate that was 7.4% higher than inflation, and clinical trials bear responsibility for most of that increase. However, the increasing cost of biomedical research is not reflected in an increase in the success rate of clinical development. Instead, it presents a major hindrance to innovation in the biotech industry, while the public must bear the brunt of the problems, absorbing the steep rise in the prices of drugs and medical devices. In order to boost the efficiency of the biotechnology industry, remove the burden of expensive drugs, and create life science products in line with the future of healthcare, we should be asking how best to modify the development process to make it cost-effective.

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  • Study Sites: Too Many Vendors, Too Little Time

    15 March, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    Sound familiar? Sprinkle in some colorful adjectives and it probably does -- these problems are common enough at clinical research sites. Equipment and systems have become increasingly technical and specialized, and study site staff has had to contend with more technology than ever before. And because of the proliferation of niche vendors who provide the new tech, sites have had to deal with more vendors than ever before, too.

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  • Why We Trek to Trade Shows

    14 March, 2016 Jill Bumgardner, Global Events Manager, MasterControl

    Most people generally support the notion that trade shows are still relevant, but sometimes a little pep talk is in order.

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  • Leveraging Quality Management Systems to Visualize and Mitigate Risk at a Cross-Enterprise Level

    11 March, 2016 Robyn Barnes, Marketing Communications, MasterControl

    You may be familiar with what a quality management system (QMS) is, but do you know how to use one at a cross-enterprise level?

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  • How to Explain Your Quality Job to Young Kids in 4 Steps

    10 March, 2016 Lillian Erickson, Global Quality Manager, MasterControl Inc.

    When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk to her first-grade class. I dreaded it. How do you explain to 6- and 7-year-olds what a quality manager does?

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  • The #1 Cause of Medical Device Recalls—and How to Avoid It

    8 March, 2016 Lisa Weeks, MasterControl Communications

    Would it surprise you to learn that the most common cause of medical device recall, according to the FDA, is software design failure? It shouldn’t. These days, it’s hard to find a device that doesn’t rely on the use of sophisticated software to operate. What’s more, a defective software component is often harder to detect than, let’s say, a defective electrical component. It really is the perfect recipe for design disaster, but it doesn’t have to be—if you know how to use risk.

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  • ISO 13485:2016 What are the Changes About?

    3 March, 2016 Linda Chatwin, Esq, RAC Manager Medical Regulatory Advisory Services, North America UL LLC

    ISO had published the final draft of the latest ISO 13485 quality management standard for medical devices, and placed it out for voting on October 29, 2015. After a two-month approval voting period, the standard was approved for official publication. For background, once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed, and only negative comments with well-reasoned, technical justification would be considered. Each technical reason is addressed in a comments resolution meeting, so that the parties resolve issues before the standard is published.

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  • Quality by Design Part 1: You Can't Design Something You Don't Understand

    1 March, 2016 Beth Pedersen, Marketing Communications, MasterControl

    Just like every other aspect of a product, quality is determined by the decisions you make in the design stages. While spending less time on planning upfront might seem to save you money, the costs associated with poor quality resulting from early design decisions can ultimately equate to 40 percent of your company’s total revenue. Correctly understanding the true nature of quality and addressing it in the design stages rather than trying to bring it in as an afterthought is the central premise of Quality by Design (QbD), and adhering to this principle could be the most cost-saving measure your company will ever take.

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  • Curing Document Control Conundrums: A Checklist for Sustained Efficiency and Audit Readiness

    25 February, 2016 James Jardine, Marketing Communications, MasterControl Inc.

    If a document control system exists to improve your organization’s productivity and help maintain a continual state of audit readiness, what rudimentary features does it absolutely need to have? The components that are deemed essential may vary slightly from one organization to the next based on individual business requirements, but the following checklist covers the minimum functionality that should be expected from a categorically complete document control software solution.

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  • The Past, Present and Future of CAPA

    23 February, 2016 James Jardine, Marketing Communications Specialist, MasterControl

    Every day, companies in regulatory environments are amplifying their efforts to avoid the seemingly inescapable consequence of an egregiously oversaturated corrective and preventive action program, or, as it’s commonly come to be known, “Death by CAPA”. A recent MedTech Intelligence article by CAPA guru Ken Peterson speaks to the evolution of CAPA, discusses the refinement of effective CAPA programs and hints at what is on the CAPA horizon in the future.

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  • The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients

    18 February, 2016 Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., and Melinda K. Plaisier, M.S.W., Food and Drug Administration

    Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review and analysis of that data, which in turn can promote the practice and culture of quality within firms.

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  • Steak, Peas, and Doughnut Holes

    16 February, 2016 Curt Porritt, SVP Marketing, MasterControl

    In a recent Q&A with Harvard Business Review, Sir David Brailsford, an MBA and former head of British Cycling, highlighted a cycling team that used a continuous improvement process to eventually find great success. Brailsford, who has overseen teams that have won more than a dozen Olympic gold medals and three Tour de France races, explained to HBR how his team focused on making small improvements in various aspects of cycling. The hope was that all of these small improvements would add up to a significant overall improvement in the team’s racing ability.

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