Showing items tagged as life sciences

  • How to Align Quality Across an Expanding Ecosystem

    7 July, 2020 By James Jardine, Staff Writer, MasterControl

    As companies grow more reliant on geographically dispersed contractors, partners, vendors and business units, it gets harder to align quality across all the entities involved. Learn how global companies like Fagron maintain quality consistency across multiple sites and discover why connecting data and processes within a robust digital platform is the surest way to align quality across your entire ecosystem.

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  • 3 Advantages of a Data-Centric Quality Mindset

    4 June, 2020 By Dale Thompson, Staff Writer

    A seismic shift is coming to life sciences manufacturing, and that’s the move from documents to data. With a data-centric mindset, it’s possible to glean valuable insights while gaining a tremendous competitive advantage.

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  • A Heartfelt Thank-You to Our Customers

    20 May, 2020 From Everyone at MasterControl

    In response to COVID-19, our customers and so many others are working hard on the front lines, behind the scenes, and everywhere in between. From everyone at MasterControl: Thank you!

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  • Weighing FDA's Response to the COVID-19 Pandemic

    19 May, 2020 by Gina Guido-Redden, Co-Founder and COO, Coda Corp USA

    The rapid global spread of the coronavirus caught many world governments and health authorities off guard. Gina Guido-Redden, co-founder and COO of Coda Corp USA, offers a comprehensive review of the how the U.S. Food and Drug Administration (FDA) has responded thus far to the pandemic under 21 CFR.

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  • Working Together to Beat COVID-19

    2 April, 2020 by Sarah Beale, Staff Writer, MasterControl

    At this point, COVID-19 has touched everyone’s life in some way. While we’re still struggling to keep up with the pandemic, many of our customers are undergoing initiatives to test and/or treat the virus.

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  • How Coronavirus, Brexit and Hurricanes Are Impacting the Global Supply Chain

    17 March, 2020 by Gina Guido-Redden, Co-Founder and COO, Coda Corp USA

    Coronavirus is the newest in a string of natural and man-made disasters and events disrupting the global supply chain. Governments and the private sector need to take a collaborative risk-management approach to planning measures to confront pandemics and other events that threaten the stability of global supply chains and our ability to meet ensuing demand.

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  • How Healthy Is Your Supply Chain?

    10 March, 2020 by Sarah Beale, Staff Writer, MasterControl

    Life sciences supply chains are unique. Pharmaceutical and medical device are even more so. Finding out industry standards and how your supply chain can improve are important questions that should be answered by the experts. Gartner recently produced “Supply Chain Benchmarking Data Reveals Differences Between Pharmaceutical and Medical Device Manufacturers” to provide those insights.

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  • In a Data-Driven Ecosystem, Don't Let Data Integrity Be Your Achilles' Heel

    27 February, 2020 by Gina Guido-Redden, Co-Founder and COO, Coda Corp USA

    Data has massive potential to revolutionize the life sciences for patients, regulators and for manufacturers. Yet at the same time, data integrity remains one of regulatory bodies’ biggest concerns. Learn what you can do to improve your company’s data integrity for regulatory inspections.

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  • 7 Steps to Ensure CAPA Success

    9 January, 2020 by Mike Rigert, Staff Writer, MasterControl

    Inadequate quality management and poor data can be costly for a life sciences company or similarly regulated industry. However, a strong corrective action preventative action (CAPA) program paired with a digital CAPA management tool can help differentiate your company from the competition.

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  • An Assessment of the ‘Elevens’: EU’s Annex 11 and FDA 21 CFR Part 11

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

    The European Union’s Annex 11 and the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 good manufacturing practice (GMP) guidances cover much of the same regulatory ground but also have differences. Find out how both regulatory documents affect life sciences manufacturers.

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  • Art Intersects With Inspiring Science Applications at the 2019 Masters Summit

    22 October, 2019 by James Jardine, Staff Writer, MasterControl

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

    17 October, 2019 by Vergel Manalo, Team Lead – Medicines and Senior Consultant, Brandwood CKC

    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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  • 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.

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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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  • R.I.P. Paper Processes

    28 February, 2019 by Heather McArthur, Sr. Director of Content Strategy, MasterControl

    For many clinical, quality and manufacturing professionals, a change in process or technologies can be hard. But now, more than ever in life sciences, there is a need to digitize and move off paper-based or hybrid solutions. Through small automation pilots, the pains of transformation get eased while opening up opportunities that unlock a wealth of data-driven insights.

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  • PwC Report Analyzes Health Care Policy Issues

    15 November, 2018 by PricewaterhouseCoopers Health Research Institute

    PwC’s Health Research Institute recently issued a report on the U.S. midterm election that analyzes policy issues that may well impact the American health care industry for years to come, particularly those in the pharmaceutical and life science industries. Learn what this means for manufacturers.

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  • Advancing the Regulatory Profession in Utah

    1 November, 2018 by Robert M. Wolfarth, Chairman, RAPS Utah Chapter

    Based on recent economic study and the establishment of the Silicon Slopes technology corridor, Utah has one of the fastest-growing life sciences communities in the U.S. Learn about the Regulatory Affairs Professionals Society’s (RAPS) new Utah Chapter and what the organization is doing to attract more regulatory affairs experts to life sciences careers.

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  • What's Hiding in Your Labeling Artwork?

    23 October, 2018 by Dan Vuksanovich, Regional Sales Manager, Schlafender Hase

    Because there are potential but invisible risks inherent in labeling artwork documents of life science companies that can’t be detected through manual proofreading, it’s important to be thorough and to know the tricks to detect and prevent these snags from causing unnecessary delays in the manufacturing process.

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  • Regulatory Barriers to Innovation for Startups

    31 July, 2018 by Tifany Desprez, Ph.D., Communication and Marketing Manager with MasterControl European Partner, Apsalys

    France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.

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