GxP Lifeline
  • 2019-bl-thumb-the-road-to-digital-manufacturing

    Digital Supply Networks and Smart Factories: The Future of Manufacturing

    The further we go into the 21st century the more it becomes apparent that the future of manufacturing will be digital. Find out how digital supply networks and smart factories will form the backbone of the digital transformation and what role quality and an automated quality management system (QMS) will play as manufacturing enters the Fourth Industrial Revolution.

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  • 2019-bl-thumb-prepare-for-the-future-of-quality-now

    5 Ways to Prepare for the Future of Quality Now

    The future of quality is closer than you might think, and the time to prepare is now. During the 2019 Masters Summit, MasterControl Partner KPMG presented a session on the future of quality and how it can help the life sciences industries now.

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  • 2019-bl-thumb-survive-holiday-cooking-with-recipe-management

    Survive Holiday Cooking With Recipe Management

    If you’re stressed about holiday meal preparation, get some help from digitizing your system. Trade out the flour-crusted recipe notecards for a recipe management system that brings precision to your cooking. This year, it’s the only way to face your in-laws with confidence.

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  • 2019-bl-thumb-fda-unveils-draft-guidance-on-asca

    The FDA Unveils Draft Guidance on ASCA for Device Conformity Assessment Testing

    The U.S. Food and Drug Administration (FDA) recently received draft guidance on its proposed pilot program, the Accreditation Scheme for Conformity Assessment (ASCA), for medical device premarket reviews. The intent of the pilot is to realize greater efficiencies and confidence in the testing and reviews process for all involved parties. Find out if ASCA might be viable for your organization.

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  • 2019-bl-thumb-world-quality-day

    World Quality Day 2019: Celebrating the Past, Present and Future of Quality

    Have you ever thought about what quality means to you? It may mean something different to everyone, but its power to change lives for the better unites people around the world. On World Quality Day, we celebrate this uniquely human concept and the impactful work of quality professionals everywhere by taking a moment to reflect on the past, present and future of quality.

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  • 2019-bl-thumb-validation-conference-takeaways

    Top 4 Takeaways From Validation Week

    In October, the 25th Annual Validation Week was held in Las Vegas, Nevada. The presenters included current and former employees of the U.S. Food and Drug Administration (FDA), and validation experts from the life sciences. This article explores the prevalent themes from the conference and how they will change validation.

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  • 2019-bl-thumb-top-trends-new-improved-validation

    Top Trends for New and Improved Validation

    Technology’s getting more advanced and our validation practices are finally starting to catch up. During the 2019 Masters Summit, Validation Product Manager Erin Wright gave us a glimpse at what’s in the future. Read about the next big trends in validation, including the U.S. Food and Drug Administration’s (FDA) stance.

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  • 219-bl-thumb-rip-paper-processes

    Manufacturers See Sizable Gains in the Leap From Paper to Digital Data

    The digital transformation and the ensuing War on Paper are changing the way life sciences manufacturers view speedy yet compliant production and the way they calculate ROI. Increasingly, companies are foregoing manual data systems in favor of a more efficient and cost-effective digital solution.

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  • 2019-bl-thumb-top-5-reasons-to-join-the-war-on-paper

    Top 5 Reasons to Join the War on Paper

    The War on Paper is being waged against paper-based systems and is won by digitizing. Recently, MasterControl partnered up with DocuSign on a webinar discussing the benefits of going digital. Read some of the highlights or watch the webinar recording if you missed it.

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  • 2019-bl-thumb-mdm-minneapolis-takeaways

    Productive Connections: Integrating Quality and Production

    In a recent presentation at MD&M Minneapolis, Terrance Holbrook, director of product at MasterControl, and Robert DePalma, VP of regulatory affairs at Pyrexar Medical, explained how manufacturers that digitally connect their production record system with other data sources will quickly stand apart from competitors.

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  • 2019-bl-thumb-brandwood-transition-from-mdd-to-mdr

    Q&A: Device Manufacturers’ FAQs on the EU’s Medical Device Regulation (MDR)

    Medical device manufacturers globally are grappling to recertify their devices against the European Union’s new Medical Device Regulation (MDR), which takes affect May 26, 2020. To help manufacturers make sense of the MDR, a Q&A was conducted with two medtech subject matter experts who tackle some of the most commonly asked questions about the MDR and how to approach it.

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  • 2019-bl-thumb-summit-irene-brodsky

    Art Intersects With Inspiring Science Applications at the 2019 Masters Summit

    Science and art may seem to have few commonalities, but creative achievements like origami models and musical compositions are closely linked with beneficial scientific applications, according to the keynote addresses at the 2019 Masters Summit. Learn about the insights that origami innovator Dr. Robert Lang and independent filmmaker Irene Taylor Brodsky have discovered in the space where art and technology intersect.

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  • 2019-bl-thumb-how-the-tga-regulates-drugs-and-devices

    Tips on How the TGA Regulates Drugs, Devices and Combination Products

    Global regulatory requirements are seemingly in a state of constant flux. Thus, it can be confusing for life sciences companies to grasp the exact nature of each region’s regulatory agency policies. This article breaks down some of the regulatory basics and more nuanced portions of Australia’s Therapeutic Goods Administration (TGA).

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  • 2019-bl-thumb-data-integrity-conf-takeaways-1

    Top 5 Takeaways From IVT’s Data Integrity Validation Conference

    The Institute of Validation Technology (IVT) recently hosted its fifth annual Data Integrity Validation conference (Aug. 14-15) in Waltham, Massachusetts. Subject matter experts from a variety of life sciences industries discussed critical aspects of data integrity and why it remains one of the most common inspection findings. This article highlights the valuable insights attendees gained about data management technologies and best practices.

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  • 2019-bl-thumb-respost-cloudly-with-chance-of-awesomness

    How Cloud Migration Has Become More Seamless for Regulated Companies

    Cloud technology has reached a level of maturity where many regulated companies are discovering that operating in the cloud is more cost effective and a competitive advantage. A new white paper discusses the benefits of moving to the cloud and how companies can make the migration process smoother and faster.

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  • 2019-bl-thumb-going-green-packaging-nutraceuticals-trends

    Top 5 Nutraceutical Trends: Going Green With Packaging

    Plastic is the new GMO. It’s experiencing similar ostracization due to the large amounts of plastic produced each year that winds up in landfills and in the ocean. Moving away from a plastic dependency requires nutraceutical companies to be prepared with innovative ideas and a manufacturing process that is easily adaptable.

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  • 2019-bl-thumb-manufacturing-with-lean-digitization

    How Digitization Can Help Life Sciences Manufacturers Amplify Lean Principles

    Life sciences manufacturers are grappling for every advantage they can get in saturated, highly competitive markets. The implementation of lean programs is one way to achieve greater efficiencies. But in order to fully realize the benefits of lean, manufacturers need to replace manual paper-based data systems with a digital production records solution.

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  • 2019-bl-thumb-wellington-foods-logo

    Shop Floor Perspective: How Eliminating Paper Elevates the People at Wellington Foods

    As the manufacturing floor becomes more digitized and automated, a curious thing is happening. Instead of replacing human workers, advanced tech is highlighting the importance of people as decision-makers and innovators. The lesson that many companies are now learning firsthand is that if digital transformation is to fully deliver on its potential, it must support and adapt to human processes and preferences, not the other way around.

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  • 2019-bl-thumb-ispe-and-mx

    Pharma Companies See Measurable ROI With Digitized Manufacturing

    Pharmaceutical manufacturing typically functions in a constant flurry of hard-to-satisfy demands, ranging from stringent compliance requirements and production schedules to developing strategies for continuous improvement. One of the presentations at the 2019 ISPE Annual Meeting and Expo, Oct. 27-30 in Las Vegas, will provide attendees with insight on how pharmaceutical companies are using digital technologies to avoid manufacturing obstacles while strengthening their competitive posture in the industry.

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  • 2019-bl-thumb-socra-conference-associations

    3 Clinical Trends Shaping the Medical Device Space in 2019

    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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