GxP Lifeline

 

  • 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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  • #QualityChangesEverything

    1 May, 2019 by Sara Bresee, Executive Vice President of Marketing, MasterControl

    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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  • The Future of Quality Meets the Future of MasterControl

    1 May, 2019 by Beth Pedersen, Staff Writer, 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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  • Achieve Greater Operational Compliance and Efficiencies in Pharma Through IDMP Implementation

    30 April, 2019 by Frits Stulp, Managing Director, Iperion Life Sciences Consultancy

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

    30 April, 2019 by Jae D. Yoo, PhD, MBA, Chief Technology Officer, Aprecia Pharmaceuticals

    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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  • Enlist in the Paperless Revolution: Gain the Digital Advantage

    25 April, 2019 by Mike Rigert, Staff Writer, MasterControl

    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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  • Establishing a Robust Human Factors Engineering Process in Development

    23 April, 2019 by Tressa Daniels, Senior Manager of User Experience Design and Human Factors Engineering, Becton Dickinson

    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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  • Top 5 Nutraceutical Trends in 2019 - Cannabis Is In

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

    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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  • What Is a Quality Control System and How Can an EQMS Give it a Boost?

    16 April, 2019 by David Butcher, Staff Writer, MasterControl

    Life science and other companies doing business in FDA- and ISO-regulated environments understand how critical quality control and quality assurance are to successful quality management. “Quality control” and “quality assurance” are often used interchangeably when referring to activities conducted to ensure the quality of a product, service or process. Some quality control and quality assurance activities are interrelated, but the two are not necessarily interchangeable. Understanding the difference between the two quality processes is important, and a robust electronic quality management system (EQMS) will enable organizations to better manage both.

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  • Coming Soon: The New Look of MasterControl

    11 April, 2019 by Beth Pedersen, Staff Writer, MasterControl

    A lot has changed since MasterControl’s beginning in 1993. As technology transforms the way we do business and quality becomes a true competitive advantage, MasterControl is evolving to better support the companies and industries we serve. We’re excited to announce that MasterControl will unveil a new look on May 1.

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  • Big Data Trends Urge Life Sciences Executives to Modernize Key Business Functions

    10 April, 2019 by David Jensen, Staff Writer, MasterControl

    A new phase of the Industrial Revolution is ushering in new technologies and modernized operational strategies that no life sciences industry executive can afford to ignore. Regulated companies are highly encouraged to plan for future relevance and success by modernizing key processes and operations.

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  • 2019 Med Device Trends: Products Most Likely to Shine

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

    Don’t expect a breakthrough technology such as 3D printing or AI-driven medical devices this year. Instead, industry experts anticipate that existing innovative products will gather momentum — among them: devices for minimally invasive procedures, light-therapy-based devices, and human cells, tissues, and cellular and tissue products (HCT/P).

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  • Rise in Data Integrity Violations Prompts FDA Guidance on Data Handling

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

    Noticing an increase in violations of current good manufacturing practices (CGMP) regarding data integrity, the U.S. Food and Drug Administration (FDA) drafted a question-and-answer-based guidance to address some of the frequently asked questions and to clarify the role of data integrity in drug manufacturing.

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  • Technical Validation: A Bottleneck in the Drug Registration Process?

    3 April, 2019 by Sandra Fadel, Product Management eCTD Templates and EURS Validator, EXTEDO

    In order to maintain the highest standards, regulatory bodies are continually tweaking their drug registration requirements for highly controlled products. To keep up with these changes and avoid costly technical errors during the submissions process, pharma organizations are making sure they’re up to speed with regulators’ most up-to-date validation criteria.

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  • Thriving in a Digital Era, Part 2

    2 April, 2019 by David Jensen, Staff Writer, MasterControl

    Part 2 of the “Thriving in a Digital Era” article series takes a deep dive into how companies are strategically mapping out their future by leveraging modernized technologies and moving their critical business functions to the cloud.

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