GxP Lifeline

 

  • 3 Clinical Trends Shaping the Medical Device Space in 2019

    19 September, 2019 by Mike Rigert, Staff Writer, MasterControl

    The medical device industry is changing at a pace that most in the industry are struggling to keep up with. And nowhere is that more evident than in medtech’s clinical research and trials space. Glean some of the hottest new clinical trends as we move into Q3 and Q4 of 2019.

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  • Uncertainty Regarding EU MDR Underscores Importance of Certification Preparation

    17 September, 2019 by Mike Rigert, Staff Writer, MasterControl

    Europe’s new regulation for medical devices, the Medical Device Regulation (MDR) takes effect May 26, 2019. Due to confusion regarding the regulation’s requirements and a lack of Notified Bodies to recertify medical devices under the new law, greater clarity is needed. Learn the latest on the developing situation and what med dev companies can do to prepare to recertify their devices.

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  • Novartis’ Data Manipulation Case a Cautionary Tale for Transparency Through Digitization

    12 September, 2019 by Mike Rigert, Staff Writer, MasterControl

    Poor data integrity and data mismanagement can be costly for life science companies, delaying their products from getting to market, and in some cases, resulting in civil and criminal penalties. The Swiss pharmaceutical manufacturer Novartis is currently under fire after the FDA said the company falsified testing data prior to the release of its drug Zolgensma. It’s a cautionary note about why now, perhaps more than ever, greater transparency is needed in data management.

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  • Life Sciences Companies Can Achieve Greater ROI by Digitizing Their Data

    10 September, 2019 by Bryant Headley, Customer Success Executive-Governments, MasterControl

    Though we’re well into the 21st century, document control in the life science and health care sectors remains largely a paper-based system. Learn from a seasoned professional who worked for the U.S. Food and Drug Administration (FDA) and the U.S. Department of Veterans Affairs how going digital can significantly reduce risk while simultaneously providing you with both greater soft and hard ROI.

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  • WD-40 Team Tells Why Quality Is Priority No. 1

    5 September, 2019 by David Jensen, Staff Writer, MasterControl

    WD-40 has been silencing squeaks and vanquishing rust and corrosion all over the world since 1953. This success story can be attributed to the product’s secret formula. To the company’s employees, the WD-40 legacy is largely due to effective quality management. In a new video, several WD-40 staff members tell how quality is the company’s number one priority.

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  • Paperless Manufacturing: 3 Metrics That Matter

    3 September, 2019 by David Butcher, Staff Writer, MasterControl

    In initial conversations, life sciences companies considering a move to digital production records told MasterControl they anticipate they will be able to achieve 30% efficiency gains, according to a MasterControl customer spotlight titled “Metrics That Matter for Quality Manufacturing.” This blog post offers a glimpse of how those expectations are becoming reality as new data is collected.

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  • Deflating Common QMS Misconceptions: Your Transition from Class II to Class III Devices

    29 August, 2019 by Andrea Pilon Artman, Founder, SpectRA Compliance

    Medical device manufacturers are often confused about the regulatory requirements when expanding their product line from Class II devices to also include Class III devices. Learn what is and what is not required of your quality management system (QMS) and premarket approval application for Class III devices.

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  • 4 Change Control Pain Points in High-Stakes Manufacturing (and How to Overcome Them)

    28 August, 2019 by Connor White, Public Relations Intern, MasterControl

    Documenting change control is a crucial part of the manufacturing process. Without it, operations can become error-ridden, ineffective and at worst – they can result in costly product recalls that are damaging to consumers and companies. Learn how a digital quality management system can ensure product quality, safety and prevent delays and recalls.

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  • Prelude to an FDA Warning Letter

    27 August, 2019 by David Jensen, Staff Writer, MasterControl

    Receiving an FDA warning letter usually sets off a chain reaction of required responses, follow-up tasks and additional correspondence that effectively keeps a regulated company from getting product out the door. This article discusses some of the common reasons life sciences companies receive warning letters and provides tips on how to avoid receiving one.

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  • Q&A: EpiBone on Digitizing and Automating Their Production Records

    22 August, 2019 by David Butcher, Staff Writer, MasterControl

    In this Q&A, EpiBone’s quality assurance manager and quality assurance specialist explain why and how the Brooklyn-based regenerative medicine company chose to digitize and automate their production records with MasterControl’s Manufacturing Excellence solution.

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  • 6 Tips for a Successful Transition to the EU MDR

    21 August, 2019 by Jenny Lin, Consultant, Brandwood CKC

    Considering the uncertainties surrounding the European Union’s implementation of the Medical Device Regulation (MDR) beginning in May 2020, many device makers are wondering how to proceed toward certification. Despite a lack of official guidance, there are several steps medical device manufacturers can do to prepare themselves to certify and implement Europe’s new regulations.

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  • MasterControl Among 2019 Pharma Innovation Award Winners

    20 August, 2019 by David Jensen, Staff Writer, MasterControl

    Despite some initial hesitancy with advancing technology, health care-related industries are making significant strides in innovation and modernization. The emergence of digitized mobile and wearable medical devices, medical apps and telemedicine technology is evidence that life sciences companies are becoming leading drivers of innovation.

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  • Product Recall Prevention and Recovery: 4 Critical Steps

    15 August, 2019 by James Jardine, Staff Writer, MasterControl

    Even the slightest oversights or errors can lead to product recalls. Learn about the primary causes of recalls, how regulators classify recalls, the four critical steps of recall recovery, and strategies that can help you avoid recalls altogether.

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  • EU MDR: How Will Europe’s New Device Regulation Affect Software?

    13 August, 2019 by Camille Bouscaud, Quality Engineer Consultant, Apsalys

    The European Union’s Medical Device Regulation (MDR) will replace the older Medical Device Directive beginning in May 2020. While this is presenting new regulatory challenges to device makers, medtech companies also need to consider how MDR will impact their production data and software systems. Companies that are well-prepared and have a robust quality management system will be best positioned to implement the new regulation.

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  • 5 Quotes From Sun Tzu to Help You Digitize

    8 August, 2019 by Sarah Beale, Staff Writer, MasterControl

    When fighting the War on Paper, it helps to turn to the foremost expert on war. Sun Tzu offers words of wisdom for starting to digitize, getting support from your organization, and how to build upon your successes. Here are five quotes from The Art of War to inspire you to take the battle to your office and permanently get rid of paper.

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  • Top 5 Nutraceutical Trends of 2019 – Pet Supplements

    6 August, 2019 by Sarah Beale, Staff Writer, MasterControl

    Supplements aren’t just for people anymore. The pet supplement market has grown with the human supplement market and there’s every indication that it will continue to do so. Taking advantage of this trend involves producing better quality supplements, conducting clinical research, and embracing technology to improve production.

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  • DIA Global 2019 Recap: 3 Themes Shaping the Future of Life Sciences

    1 August, 2019 by James Jardine, Staff Writer, MasterControl

    Patient centricity, transformative technologies and the importance of high-quality and clinically meaningful data were the major themes at DIA Global 2019. Learn about the trends having the biggest impact on the evolving life sciences landscape.

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  • 5 Ways Digital Technology Will Transform the Supply Chain

    30 July, 2019 by David Butcher, Staff Writer, MasterControl

    Advances in digital tools and technologies promise to improve supply chain performance and help usher in the next-generation digital supply chain, Supply Chain 4.0. For global life science companies, this digital revolution has enormous implications for the supply chain.

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  • How the Cloud Is Propelling the Golden Age of Life Sciences Startups

    25 July, 2019 by James Jardine, Staff Writer, MasterControl

    By getting FDA approval for its wearable technology just two years after its founding, BraveHeart Wireless is proving that there has never been a better time for startups in the life sciences to embrace cloud technology. Learn how cloud-based solutions are accelerating BraveHeart’s successes.

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  • The New Era of Food Safety Is Digital

    23 July, 2019 by Sarah Beale, Staff Writer, MasterControl

    The U.S. Food and Drug Administration (FDA) is looking to build on the Food Safety and Modernization Act (FSMA) to use digitization to improve food safety. This “New Era of Smarter Food Safety” introduces concepts that fully embrace technological innovation and encourage food companies to use digitization to avoid future problems while complying with FSMA.

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