GxP Lifeline

 

  • Avoid FDA Audit Findings on Your Device by Performing Process Validation

    27 June, 2019 by Dan O'Leary, President, Ombu Enterprises

    Medical device makers could save themselves time and heartache in reducing the number of regulatory findings when it comes to the FDA’s CFR Part 820 quality system regulations and ISO 13485. How? By understanding the benefits you get by fully implementing process validation to achieve higher levels of compliance.

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  • Beyond Quality: Leveraging Technology to Build a Quality Culture, Part 2

    25 June, 2019 by James Jardine, Staff Writer, MasterControl

    Quality 4.0 technologies are becoming ever more vital for prosperity. Learn why LNS Research and MasterControl say the experiences of early adopters have laid the groundwork for life sciences companies that are searching for successful industrial transformation (IX) strategies that combine mature technology with a business-first approach.

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  • Study: Effluvial Lodging for Mice Negatively Impacts Data Quality

    20 June, 2019 by David Jensen, Staff Writer, MasterControl

    Researchers at the University of British Columbia (UBC) discovered that laboratory mice are not only biologically similar to humans, they also have similar aesthetic attributes. A recent study revealed that mice actually don’t like to sleep in sewage waste. Aside from affirming that mice might have some level of dignity and social grace, the study suggests that consistently exposing mice to “chronic averse stimuli” can negatively affect research data.

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  • Top 5 Nutraceutical Trends in 2019 — Nutricosmetics

    18 June, 2019 by Sarah Beale, Staff Writer, MasterControl

    In 2019, more nutraceutical companies are nudging their way into the cosmetics space with the concept of “beauty from within.” With a focus on how nutrition affects physical appearance, nutricosmetics bridge the gap between nutrition and beauty and open new opportunities for supplement companies.

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  • On the Road to More Efficient Manufacturing: A Digital Solution

    13 June, 2019 by Mike Rigert, Staff Writer, MasterControl

    Global Positioning Systems (GPS) have largely replaced the way people navigate the world. In a similar fashion, manufacturers are increasingly turning to digital solutions to navigate production records and data management, resulting in fewer production errors, less waste and faster time to market – key advantages in a tightly contested marketplace.

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  • 5 Key Questions About Quality Agreements

    11 June, 2019 by Arvilla Trag, RAC, Consultant, BioProcess Technology

    Quality agreements between organizations and contract manufacturing organizations (CMO), particularly in pharma, can be crucial to increasing ROI for a manufacturer. But there is a right way and a wrong way to approach quality agreements. Learn some best practices on how to produce more efficient and effective quality agreements.

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  • Beyond Quality: Leveraging Technology to Build a Quality Culture, Part 1

    6 June, 2019 by James Jardine, Staff Writer, MasterControl

    Why is it so difficult for life sciences companies to streamline their manufacturing operations and overcome recurring quality monitoring and analytics obstacles? Learn why LNS Research and MasterControl say the secret to efficiency can be found in the convergence of technology, manufacturing and Quality 4.0 — and why quality professionals should be at the forefront of modernization.

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  • Turning Mistakes Into Marvels on the Manufacturing Floor

    5 June, 2019 by Jared Evans, Lean Process Coach and Professional Instructor, MasterControl

    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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  • How Digital Document Control Boosts Manufacturing Efficiency

    4 June, 2019 by David Jensen, Staff Writer, MasterControl

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

    30 May, 2019 by James Jardine, Staff Writer, MasterControl

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

    29 May, 2019 by Cindy Fazzi, Staff Writer, MasterControl

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

    28 May, 2019 by Armando Coronado and Vidhya Ranganathan, Consultants, Sequence

    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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  • 4 Common Fears and Misconceptions About Cloud Validation

    23 May, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    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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  • Surviving the Perfect Storm – International Harmonization for Medtech

    22 May, 2019 by Grant Bennett, CEO, Brandwood Biomedical

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

    21 May, 2019 by James Jardine, Staff Writer, MasterControl

    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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  • A Guide to Pharmaceutical Quality by Design

    16 May, 2019 by Beth Pedersen, Staff Writer, MasterControl

    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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  • Completing the Lean Manufacturing Journey With Digitalization

    14 May, 2019 by Dave Edwards, Executive Vice President, MasterControl

    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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  • 2019 Med Device Trends: Digital Health Will Move Onward

    9 May, 2019 by Cindy Fazzi, Staff Writer, MasterControl

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

    7 May, 2019 by Mike Rigert, Staff Writer, MasterControl

    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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  • Preparing for a Recall Armageddon

    2 May, 2019 by Sarah Beale, Staff Writer, MasterControl

    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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