• 2019-bl-thumb-turning-mistakes-into-marvels

    Turning Mistakes Into Marvels on the Manufacturing Floor

    Errors. Oversights. Accidents. Mishaps. Bloopers. Gaffes. Fails. Call them what you will, mistakes on the manufacturing floor are unavoidable. And while they usually carry a negative connotation, sometimes a mistake can make a lasting impact for the better.

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  • 2017-bl-thumb-what-is-doc-control-system

    How Digital Document Control Boosts Manufacturing Efficiency

    Regulated companies are often reminded that if it isn’t documented, it didn’t happen. It’s also safe to say if it is documented, but the documents can’t be found, it didn’t happen. Efficient document control is at the core of quality management, compliance and getting products out the door.

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  • Human_automation_v2_132x132

    The Evolving Role of Humans in an Automated World, Part 2

    Can we maximize the benefits of automation without minimizing our humanity? Learn how to stay human in an automated world and explore real-world examples of life sciences professionals who enhance their capabilities by leveraging advanced automated tools.

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  • 2017-bl-thumb-top-iso-13485

    FDA’s Plan to Replace QSR With ISO 13485: Pros and Cons

    The U.S. Food and Drug Administration (FDA) plans to replace the Quality System Regulation (QSR) with ISO 13485. An announcement of a formal rule change is expected this fall, so GxP Lifeline asked three medical device industry experts and the Advanced Medical Technology Association (AdvaMed) to weigh the pros and cons of the plan.

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  • 2019-bl-thumb-quality-control-laboratory-data-mgt

    7 Key Elements to Data Security and Quality Control for Pharma Labs

    Due to a growing number of U.S. Food and Drug Administration (FDA) CGMP violations involving data integrity, pharmaceutical companies are looking for ways to improve good manufacturing and lab practices. This article looks at a number of options pharma has to enhance data integrity and to ensure the safety, efficacy and quality of its products.

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  • Tips for Life Science Companies to Thrive in a Digital Era | MasterControl

    4 Common Fears and Misconceptions About Cloud Validation

    Unsure about cloud validation? You’re not alone. Many life sciences and other regulated companies are unfamiliar with cloud-based quality management system (QMS) and wary about its validation. After all, their regulatory compliance is at stake.

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  • 2019-bl-thumb-brandwood-biomedical-1

    Surviving the Perfect Storm – International Harmonization for Medtech

    The evolution of regulatory changes in the European Union with it’s Medical Device Regulation (MDR), the U.K.’s Brexit, and changes in Canada and elsewhere are creating a global ripple effect in the medical device industry. These hurdles may cause uncertainty for device makers, but through careful preparation and planning, medtech companies adjust their strategies and approaches during this transitionary period.

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  • Human_automation_132x132

    The Evolving Role of Humans in an Automated World, Part 1

    Are our automated tools merely machines that complement and simplify our work, or will they ultimately make us obsolete? Learn why humans and their ability to solve problems and interpret information will always be the core component of any automation initiative.

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  • 2020-bl-manufacturing-excellence-06_132x132

    A Guide to Pharmaceutical Quality by Design

    Quality by Design (QbD) continues to be a hot topic across the life sciences industries. As more of the pharma sector implements pharmaceutical QbD, regulatory bodies work to further develop a common understanding of key concepts, terminology and expectations.

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  • 2019-bl-thumb-completing-the-lean-journey-with-digitization

    Completing the Lean Manufacturing Journey With Digitalization

    Many occupying the manufacturing C-suite have embraced the principles of lean manufacturing and continuous improvement because they affect their bottom line. Yet a large portion of manufacturers continue to rely on error-prone, costly document management and recordkeeping systems on the shop floor. Reap the greatest benefits from lean by embracing the digital transformation and upgrading your organization’s culture of quality.

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  • 2018-bl-thumb-top-med-device-trends-asia-pacific

    2019 Med Device Trends: Digital Health Will Move Onward

    If this year’s Consumer Electronics Show (CES) is any indication of things to come, we can expect the role of medical devices in digital health to move onward and upward. The popular annual trade show attracted over 500 exhibitors of digital health products, including hundreds of medical devices.

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  • 2019-bl-thumb-humans-and-robots-on-the-factory-floor

    Humans and Robots on the Factory Floor: The Future of Quality Manufacturing

    Robots and humans in factories of the future may well work more synergistically. However, many manufacturers have yet to adopt the principles of Industry 4.0 for digitized data directly on the shop floor. Costly, time-consuming paper-based document control processes are holding your company back. Learn how to increase quality and efficiencies through Industry 4.0 and Quality 4.0 to achieve a truly 21st century manufacturing organization.

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  • 2019-bl-thumb-preparing-for-recall-armageddon

    Preparing for a Recall Armageddon

    Recalls can seem like the end of the world, but new FDA guidance seeks to change that. With a focus on training, record keeping and procedures, the recommendations are most effective with the help of automation and digitization.

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  • 2019-bl-thumb-quality-changes-everything-2

    #QualityChangesEverything

    Beginnings are important because they often give a first impression. Today is a landmark day for MasterControl as we introduce not just our new look and feel, but also a renewed commitment to customers and an integrated platform of enterprise solutions. Today changes everything because #QualityChangesEverything.

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  • 2019-bl-thumb-quality-changes-everything

    The Future of Quality Meets the Future of MasterControl

    Quality and compliance are not what they were 25 years ago, 10 years ago, or even five years ago. And neither is MasterControl. Today, we launch the new MasterControl brand.

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  • greater-operational-compliance-thumb

    Achieve Greater Operational Compliance and Efficiencies in Pharma Through IDMP Implementation

    The Identification of Medicinal Products (IDMP) is a set of ISO data standards that will help ensure that pharma organizations around the world speak the same language when it comes to product information and definitions. Find out how IDMP can also help improve your company’s internal quality processes.

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  • 2019-bl-thumb-3d-printing-of-pharmaceuticals

    3D Printing of Pharma Dosage Forms a Promising New Tech for Discovery

    Pharmaceutical manufacturers depend on innovation and new technologies to find new cost-effective ways of speeding up the drug development process. 3D printing (3DP) allows greater flexibility during the discovery process through rapid prototyping formulations and the potential for on-demand production of clinical samples. Learn how 3DP may change the way pharma does business.

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  • 2019-bl-thumb-war-on-paper-arbor-day

    Enlist in the Paperless Revolution: Gain the Digital Advantage

    Revolutions often take just the smallest act to become a widespread movement for change. J. Sterling Morton kicked off a worldwide forestation revolution in 1872, aka, Arbor Day. And digital transformation is currently revolutionizing the way life sciences and manufacturing companies do business. Declare “War on Paper” by joining the call to arms to go paperless.

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  • 2020-bl-mc-insights-01_132x132

    Establishing a Robust Human Factors Engineering Process in Development

    Human factors engineering (HFE), also called usability engineering, in an essential part of user experience design and a major component in ensuring that human well-being and system performance are optimized. Learn why device manufacturers can best benefit from HFE processes when they are integrated into the existing product development phase.

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  • 2019-bl-thumb-top-5-nutraceutical-trends

    Top 5 Nutraceutical Trends in 2019 - Cannabis Is In

    Cannabis is in. It’s achieved a level of trendiness that few, if any, ingredients ever have. Nutraceutical companies are pushing the envelope when it comes to cannabis products, but there are a number of legal ramifications that need to be considered before jumping into this market.

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