GxP Lifeline
  • 2020-bl-mpr-risk-management_132x132

    ISO 14971:2019 Risk Management for Medical Device: Keeping up with current expectations

    With the update to internationally recognized standard ISO 14971: Medical devices — Application of risk management to medical devices late in 2019, many manufacturers have taken a hard look at strengthening their post-production procedures over the past year to make improvements to how risk is managed throughout the entire product lifecycle.

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  • 2020-bl-cqg-quality-mgmt-trends_132x132

    Three Quality Management Trends to Watch in 2021

    Three key trends in MedTech quality management for 2021 include a rise in eQMS adoption, the continuation of remote audits and an increase in shared supplier audits.

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  • 2020-bl-brian-curran-10-talk_132x132

    5 Advantages of Connected Manufacturing

    Every day, we use technology to make our lives easier. Similar technology is available to streamline manufacturing processes. It’s time to digitize and make production errorless, visible and connected.

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  • 2020-bl-why-c-suite-interested_132x132

    Selling the C-Suite on Connected Quality Data

    All year we’ve been addressing connected quality data. Since we’re talking about connecting data across the organization, it makes sense that there would be advantages across the organization. Getting executive buy-in requires showing your C-suite how they’ll benefit from a digital transformation.

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  • 2020-bl-q-and-a-santa_132x132

    A Q&A About the North Pole’s Manufacturing

    We recently sat down with North Pole CEO Kris Kringle to chat about how he took his operation from paper to digital. Turns out making presents for children all over the world requires a cutting-edge manufacturing solution.

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  • 2020-bl-qarad-brexit_132x132

    Brexit and the Impact on the IVD and MD Industries

    On January 1, 2021 the United Kington will leave the European Union. The implications of this move have a significant impact on manufacturers.

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  • 2020-bl-rca-virtual-audits_132x132

    Adjusting to the FDA’s new Hybrid Audit and Inspection Model

    The U.S. Food and Drug Administration is changing their approach to audits. Understand how to prepare for a virtual inspection and how to ensure it goes smoothly.

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  • 2020-bl-enterey-software-adoption_132x132

    Looking to Adopt Technology? Look at Processes First

    Managing Consultant for Enterey, John Chiechi, explains that before adopting new technology, a business must have the right processes in place.

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  • 2020-bl-additive-manufacturing_132x132

    Additive Manufacturing in the Medical Device Industry

    Additive manufacturing (AM), often referred to as 3D printing, is frequently used for product research and development in many industries and for commercial production in some, including medical device manufacturing. In the medical device industry, it is expected to grow fast, offering significant value in the production of customized, fast-to-market devices.

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  • 2020-bl-coda-corp_132x132

    The Fundamentals of Immunization, Part 3

    Learn about the leading candidates in the race for safe and effective COVID-19 vaccines and therapeutics, as well as the technologies being utilized to shepherd us to the end of this pandemic.

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  • 2020-bl-world-quality-day_132x132

    Celebrating Quality Mastery (and Mishaps) on World Quality Day

    World Quality Day 2020 provides the ideal opportunity to celebrate quality professionals who go above and beyond. It’s also a good time to have some LOLs about the quality world’s more comical and cringeworthy experiences. Giggle (or groan) along with the entries in the Quality Shorts Film Fest, and find out who won the 2020 Masters of Excellence Awards.

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  • 2020-bl-using-connected-quality_132x132

    What Connected Quality Means for Training

    For regulated companies, there’s a lot riding on training. If someone isn’t trained, the life-saving products of life sciences companies can become life-ending products. An integrated training management system gives training managers a complete picture of what’s going on with training and what they need to do next to stay on track.

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  • 2020-bl-thumb-the-next-evolution-in-manufacturing

    The Next Evolution in Manufacturing

    There’s no reason to keep living in the past when it comes to your batch review process. With review by exception, you can accelerate your processes to get product out the door faster. All while reducing frustration in both quality and manufacturing.

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  • 2020-bl-quality-architech_132x132

    Is Your QMS Robust Enough to Withstand the Long Term Effects of the Recent COVID-19 Pandemic?

    A robust, flexible quality management system (QMS) is a critical part of a business. Recent issues with COVID-19 illustrate why it is important than ever to integrate the QMS with the organization’s business continuity plan.

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  • 2020-bl-thumb-pharma-trends-brief

    The Platform Advantage: Keys to Keeping Up With Pharma’s Top 4 Trends

    Software platforms are revolutionizing the quality function. What was once a guardrail for pharmaceutical and biotech companies is rapidly becoming a business accelerator that provides quantifiable competitive advantages. Discover how game-changing platforms are empowering leading companies to adapt to four predominant pharma industry trends by streamlining the management of data and quality processes.

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  • 2020-bl-managing-compliance-costs_132x132

    EU’s MDR Calls for Summary of Safety and Clinical Performance

    With the fast-approaching Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device manufacturers will be seeing more documentation requirements. One of the new documents is a summary of safety and clinical performance (SSCP). This is one of the annual reports manufacturers must provide throughout the life cycle of a device in order to remain compliant to sell products in the EU.

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  • 2020-bl-gxp-lifeline-template_132x132

    Simplifying Part 11

    21 CFR Part 11 went into effect more than 20 years ago, and it remains a widely discussed regulation.

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  • 2020-bl-brandwood_132x132

    ISO 14971: 2019 and ISO TR 24971: 2019 Medical Device Risk Management Standards

    This article explores the definitive risk management standard for medical devices (ISO 14971) and the accompanying guidance on its application (ISO TR 24971) revised in December 2019. Although the basic foundation and structure of the risk management process has not changed from previous versions, revisions were undertaken to provide device manufactures with more clarity on critical aspects of risk management and hazard identification ensuring risk is effectively managed across all stages of the product lifecycle.

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  • 2020-bl-quva-case-study_132x132

    QuVa Pharma Fosters Agility and Growth by Going Paperless

    QuVa Pharma is a 503B compounding facility with a large catalog of medicines and a growing customer base. Read how the company has been improving its use of resources, efficiency and quality to keep up with increased production demands and tighter timelines.

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  • 2020-bl-carestream-logo_132x132

    Carestream Health: Modernizing Legacy Technology to Transform Manufacturing and Quality

    Legacy technology can be a significant barrier to digital transformation. At Carestream Health, process manager Eli Tuber is leading a digital transformation of the company’s operational technology, from outdated legacy systems to modern digital platforms. The company is taking a platform approach to technology modernization, including electronic device history records (eDHRs), to transform manufacturing performance and quality.

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