GxP Lifeline

 

  • Q&A: EpiBone on Digitizing and Automating Their Production Records

    22 August, 2019 by David Butcher, Staff Writer, MasterControl

    In this Q&A, EpiBone’s quality assurance manager and quality assurance specialist explain why and how the Brooklyn-based regenerative medicine company chose to digitize and automate their production records with MasterControl’s Manufacturing Excellence solution.

    Full story

  • 6 Tips for a Successful Transition to the EU MDR

    21 August, 2019 by Jenny Lin, Consultant, Brandwood CKC

    Considering the uncertainties surrounding the European Union’s implementation of the Medical Device Regulation (MDR) beginning in May 2020, many device makers are wondering how to proceed toward certification. Despite a lack of official guidance, there are several steps medical device manufacturers can do to prepare themselves to certify and implement Europe’s new regulations.

    Full story

  • MasterControl Among 2019 Pharma Innovation Award Winners

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

    Despite some initial hesitancy with advancing technology, health care-related industries are making significant strides in innovation and modernization. The emergence of digitized mobile and wearable medical devices, medical apps and telemedicine technology is evidence that life sciences companies are becoming leading drivers of innovation.

    Full story

  • Product Recall Prevention and Recovery: 4 Critical Steps

    15 August, 2019 by James Jardine, Staff Writer, MasterControl

    Even the slightest oversights or errors can lead to product recalls. Learn about the primary causes of recalls, how regulators classify recalls, the four critical steps of recall recovery, and strategies that can help you avoid recalls altogether.

    Full story

  • EU MDR: How Will Europe’s New Device Regulation Affect Software?

    13 August, 2019 by Camille Bouscaud, Quality Engineer Consultant, Apsalys

    The European Union’s Medical Device Regulation (MDR) will replace the older Medical Device Directive beginning in May 2020. While this is presenting new regulatory challenges to device makers, medtech companies also need to consider how MDR will impact their production data and software systems. Companies that are well-prepared and have a robust quality management system will be best positioned to implement the new regulation.

    Full story

  • 5 Quotes From Sun Tzu to Help You Digitize

    8 August, 2019 by Sarah Beale, Staff Writer, MasterControl

    When fighting the War on Paper, it helps to turn to the foremost expert on war. Sun Tzu offers words of wisdom for starting to digitize, getting support from your organization, and how to build upon your successes. Here are five quotes from The Art of War to inspire you to take the battle to your office and permanently get rid of paper.

    Full story

  • Top 5 Nutraceutical Trends of 2019 – Pet Supplements

    6 August, 2019 by Sarah Beale, Staff Writer, MasterControl

    Supplements aren’t just for people anymore. The pet supplement market has grown with the human supplement market and there’s every indication that it will continue to do so. Taking advantage of this trend involves producing better quality supplements, conducting clinical research, and embracing technology to improve production.

    Full story

  • DIA Global 2019 Recap: 3 Themes Shaping the Future of Life Sciences

    1 August, 2019 by James Jardine, Staff Writer, MasterControl

    Patient centricity, transformative technologies and the importance of high-quality and clinically meaningful data were the major themes at DIA Global 2019. Learn about the trends having the biggest impact on the evolving life sciences landscape.

    Full story

  • 5 Ways Digital Technology Will Transform the Supply Chain

    30 July, 2019 by David Butcher, Staff Writer, MasterControl

    Advances in digital tools and technologies promise to improve supply chain performance and help usher in the next-generation digital supply chain, Supply Chain 4.0. For global life science companies, this digital revolution has enormous implications for the supply chain.

    Full story

  • How the Cloud Is Propelling the Golden Age of Life Sciences Startups

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

    By getting FDA approval for its wearable technology just two years after its founding, BraveHeart Wireless is proving that there has never been a better time for startups in the life sciences to embrace cloud technology. Learn how cloud-based solutions are accelerating BraveHeart’s successes.

    Full story

  • The New Era of Food Safety Is Digital

    23 July, 2019 by Sarah Beale, Staff Writer, MasterControl

    The U.S. Food and Drug Administration (FDA) is looking to build on the Food Safety and Modernization Act (FSMA) to use digitization to improve food safety. This “New Era of Smarter Food Safety” introduces concepts that fully embrace technological innovation and encourage food companies to use digitization to avoid future problems while complying with FSMA.

    Full story

  • When Sparks Fly: Conflict Resolution for Quality and Manufacturing

    18 July, 2019 by Beth Pedersen, Staff Writer, MasterControl

    Sparks have long flown between quality and manufacturing, and the adversarial nature of their relationship seems to be an accepted reality. But rarely does the discussion move beyond simply recognizing that a conflict exists. What is the cause of the divide? How can it be bridged? And what do companies stand to gain by doing so?

    Full story

  • 3 Quantifiable Benefits Manufacturers Can Achieve by Eliminating Paper

    16 July, 2019 by James Jardine, Staff Writer, MasterControl

    In the manufacturing world, calculable metrics and reproducible outcomes are all that matter. Learn about the three main measurable benefits that manufacturers are realizing by replacing their paper-based processes and production record management practices with fully digitized systems.

    Full story

  • Overcoming Challenges in Cannabis Compliance

    11 July, 2019 by Sarah Beale, Staff Writer, MasterControl

    As cannabis legalization spreads, cannabis companies need to ensure they can keep up with their competition and regulations. A quality management system (QMS) gives these businesses the tools they need to overcome their unique challenges.

    Full story

  • A Guide for Performing and Maintaining a Validated IT Infrastructure

    9 July, 2019 by Ian Lucas, Partner and Director, SeerPharma

    It’s essential for life sciences and other regulated companies to certify that their IT infrastructure is up to specifications through system validations and qualifications, not only for better compliance, but also to ensure the quality and integrity of their data and production documentation.

    Full story

  • 5 Helpful (and Hilarious) Quotes From ‘The Big Lebowski’ That Also ‘Abide’ By Quality

    3 July, 2019 by Mike Rigert, Staff Writer, MasterControl

    “The Big Lebowski,” starring the indefatigable Jeff Bridges, has attracted a cult following over the years. The 1998 film features some of the most quotable lines in film. And, surprise — they apply to the field of quality management.

    Full story

  • 10 Ways Cloud Technology Is Reversing a Pharma Trend

    2 July, 2019 by James Jardine, Staff Writer, MasterControl

    Cloud networks, once shunned in the life sciences, have become essential tools for pharmaceutical organizations that want to keep pace with modernized competitors and an increasingly streamlined world. Learn about 10 distinct advantages cloud technology provides to pharma companies.

    Full story

  • 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.

    Full story

  • 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.

    Full story

  • 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.

    Full story