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GxP Lifeline
  • 2020-bl-thumb-med-device-ebook

    A Data-Centric Approach to Propel the Future of Device Innovation

    Technology and digital transformation are rapidly altering the way medical device manufacturers accelerate production and innovate new products. A new e-book “Mastering Data to Drive Medical Device Innovation to 2030” looks at how the medtech ecosystem is moving toward a more data-centric approach to quality manufacturing. Automated solutions integrated into a digital platform offer device makers the tools to generate real-time intelligence and insights that will lead to greater innovation over the next decade.

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  • 2020-bl-thumb-life-sciences-trends-point-spotlight-data

    2020 Life Sciences Industry Trends Point Spotlight on Data

    Data is taking on a prominent role in advanced technologies, which is rapidly changing the dynamic of innovation across all industries. A new MasterControl trend brief, “2020 Trends in Quality Data Management and Integrity for the Life Sciences,” examines new life sciences industry trends that pivot around data and how they will impact regulated companies.

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  • 2020-bl-thumb-brandwood-fda-501k-trends

    What 2019 Data Reveals About FDA’s 510(k) Program

    The U.S. Food and Drug Administration's (FDA) 510(k) pathway for medical devices is aimed at simplifying and instilling more predictability in the regulatory process. This article examines 2019 data on manufacturers’ use of the regulatory pathway and looks at some trends and takeaways for device makers.

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  • 2020-bl-thumb-your-map-to-quality-manufacturing-ripple

    Your Map to Quality Manufacturing

    Your path to quality manufacturing is simple: eliminate paper production records and digitize your shop floor. Follow these steps to achieve results that matter and drive revenue.

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  • 2020-bl-thumb-3-main-barriers-to-connected-quality

    3 Main Barriers to Connected Quality and How to Overcome Them

    Shrinking margins, intensifying competition and rapidly increasing product personalization and customization are complicating new product introduction pipelines in the life sciences. Leveraging the data connectivity capabilities of platforms is the key to overcoming these and other obstructions to a connected quality life cycle.

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  • 2020-bl-thumb-how-to-increase-the-value-of-your-supplier-audits

    How to Increase the Value of Your Supplier Audits

    A manufacturer’s ability to maintain high-quality products and regulatory compliance depends largely on its suppliers’ own quality-related activities. Leveraged correctly, supplier audits can be an important tool that gives manufacturers greater visibility into these activities, according to Quality Support Group CEO Angelo Scangas.

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  • 2020-bl-thumb-gain-competitive-edge-with-iso-certification

    How Companies Gain a Competitive Edge With ISO Certification

    The International Organization of Standards (ISO) is a global organization that defines essential requirements for helping businesses improve their products, services and customer relations. Applying these guidelines enables organizations to give their customers the assurance that their products and services are safe, reliable and of good quality. This article introduces the most popular ISO standards and discusses how companies can use them to gain a competitive edge in their markets.

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  • 2020-bl-thumb-working-together-to-beat-covid-19

    Working Together to Beat COVID-19

    At this point, COVID-19 has touched everyone’s life in some way. While we’re still struggling to keep up with the pandemic, many of our customers are undergoing initiatives to test and/or treat the virus.

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  • 2020-bl-thumb-gamp-for-risk-based-computer-validation

    Leveraging GAMP 5 Compliance for Risk-Based Software Validation

    In a life sciences industry that highly values risk reduction, Good Automated Manufacturing Practices (GAMP) principles offer key insights on computer validation. GAMP 5 offers companies guidelines that can help ensure greater computer system compliance that reduces risk.

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  • 2020-bl-thumb-3-spock-quotes-for-manufacturing

    3 Spock Quotes for Manufacturing

    In honor of Leonard Nimoy’s birthday, we’ve taken some of Spock’s words of wisdom and applied them to manufacturing. Because it’s only logical to get paper off the shop floor and fully digitize your processes.

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  • 2020-bl-thumb-8-system-requirements-ext-quality-across-ecosystems

    8 System Requirements for Extending Quality Across Expanding Ecosystems

    More and more life sciences companies are adopting asset-light models that heavily rely on a broad system of contract organizations. When supply chains expand, however, quality is often the first casualty. Learn the key questions to ask to ensure your system can enforce quality across the entire ecosystem.

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  • 2020-bl-thumb-5-most-important-things-quality-system-management

    5 Essentials to Effectively Manage a Quality System

    In the life sciences and other regulated industries, effective quality system management is essential. Companies can’t deliver a safe and effective product and comply with regulators without one. But it’s also crucial that companies take a risk-based approach to selecting and developing a quality system that's well suited to their needs. Digital QMS solutions often offer unsurpassed benefits that a paper-based system can’t deliver.

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  • 2020-bl-thumb-coronavirus-global-supply-chain-risk

    "How Coronavirus, Brexit and Hurricanes Are Impacting the Global Supply Chain"

    Coronavirus is the newest in a string of natural and man-made disasters and events disrupting the global supply chain. Governments and the private sector need to take a collaborative risk-management approach to planning measures to confront pandemics and other events that threaten the stability of global supply chains and our ability to meet ensuing demand.

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  • 2020-bl-thumb-gartner-reprint-supply-chain-pharma-medtech

    How Healthy Is Your Supply Chain?

    Life sciences supply chains are unique. Pharmaceutical and medical device are even more so. Finding out industry standards and how your supply chain can improve are important questions that should be answered by the experts. Gartner recently produced “Supply Chain Benchmarking Data Reveals Differences Between Pharmaceutical and Medical Device Manufacturers” to provide those insights.

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  • 2020-bl-thumb-5-myths-about-cloud-security

    Webinar Dispels Myths About Cloud Security

    More companies in all industries are migrating to a cloud environment to benefit from the advanced computing power, abundant data storage, and ability to perform complex functions. The cloud provides significant value; however, security has often been a source of concern. This article dispels the five most common myths about cloud security.

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  • 2020-bl-thumb-coda-corp-fda-and-data-integrity

    "In a Data-Driven Ecosystem, Don't Let Data Integrity Be Your Achilles' Heel"

    Data has massive potential to revolutionize the life sciences for patients, regulators and for manufacturers. Yet at the same time, data integrity remains one of regulatory bodies’ biggest concerns. Learn what you can do to improve your company’s data integrity for regulatory inspections.

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  • 2020-bl-thumb-3-personalized-medicine-trends-for-2020

    3 Personalized Medicine Trends for 2020

    The idea behind personalized medicine has always been the goal for health care professionals, but it’s becoming truly achievable with recent advances in technology. For pharmaceutical and medical device companies in the market, here are three trends to help you through 2020.

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  • 2020-bl-thumb-robotic-process-automation

    Life Sciences Look to Increase Productivity Through Robotic Automation

    With all the new digital technologies impacting the life sciences, don’t forget about robotic process automation (RPA). The potential of RPA to automate repetitive, data-intensive processes can increase efficiencies and quality while freeing up your staff for more meaningful functions and assignments.

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  • 2020-bl-thumb-the-love-affair-quality-manufacturing

    When Quality Met Manufacturing

    It’s February, so stores are flooded with Valentine’s Day candy, flowers and greeting cards. None of these are for the quality-manufacturing relationship, but it still deserves some attention. If your quality and manufacturing departments have enough drama to give a rom-com a run for its money, it’s time to take the first step to bringing them together.

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  • 2020-bl-thumb-epibone-video-case-study

    EpiBone Embodies Paperless Efficiencies in Personalized Medicine

    In a new case study video, EpiBone, a Brooklyn-based regenerative medicine company developing living grafts for skeletal reconstruction, explains how it is leveraging MasterControl's QMS and manufacturing software to reduce errors and increase efficiency in the management of its quality processes and production records.

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