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GxP Lifeline
  • 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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    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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    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-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-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-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-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-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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    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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  • 2020-bl-managing-compliance-costs_132x132

    CLIA Certification: 3 Things You Need to Know

    Testing accuracy and reliability are the top priorities of any laboratory that conducts tests on humans. To demonstrate their commitment to testing integrity, facilities in the U.S. must adhere to Clinical Laboratory Improvement Amendments (CLIA) quality regulations. The path to CLIA certification begins by addressing three fundamental questions.

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  • MasterControl Logo

    Aviator Proves the Sky Is Not the Limit for Life-Changing Innovation

    Read how BraveHeart Wireless Inc. earned 510(k) approval for its Life Sensor Cardiac Monitor within one year.

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  • 2020-bl-reducing-human-error_132x132

    How to Reduce Human Error on the Pharmaceutical Manufacturing Floor

    CAPA’s will be effective when we can eliminate conditions (causes) that make people deviate from the expected outcome. Therefore, CAPA effectiveness should be measured by root cause recurrence and event recurrence.

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    Using Connected Quality to Track Down Problems

    Mistakes are inevitable in any process. The problem is making sure those mistakes aren’t repeated and that any underlying issues are resolved. To do this, you need good systems in place for detecting problems, the severity of problems, determining a solution, and implementing that solution.

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  • 2020-bl-501k-guidance_132x132

    FDA’s New 510(k) Pathway Highlights Safety and Performance Data

    The U.S. Food and Drug Administration (FDA) continues to create avenues for life sciences companies to get products approved and on the market at a faster pace. The agency set up a new 510(k) pathway for achieving market approval, which is device-specific and based on safety and performance data. In pursuing this pathway, the agency emphasizes the importance of continuous improvement and effective data management.

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  • 2020-bl-bom_132x132

    3 Challenges that Bill of Materials Software Can Help Resolve

    A bill of materials (BOM) is crucial for ensuring a complete and accurate view of product parts and for protecting and analyzing the use of resources throughout the life cycle of a product. Any revision to a product’s design must be updated in the BOM, accurately identifying and listing what is required to produce the product. Because it extends to a variety of departments, BOM management often results in a number of common challenges for manufacturers.

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