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Showing items tagged as eQMS

  • 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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  • What the FDA’s New Ruling Means for Caffeine Supplements

    14 June, 2018 by Sarah Beale, Staff Writer, MasterControl

    Most of us need caffeine to get through the day, whether from coffee, soda or energy drinks. For those seeking alternate sources, nutraceutical companies have been happy to oblige. However, recent headlines about dangerous caffeine supplements and subsequent action by the FDA might be worrisome to consumers and manufacturers.

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  • The Link Between Regulation, Quality Systems and Data Integrity, Part 2

    31 May, 2018 by Philippe Charbon, CEO of Apsalys, a European value-added Partner of MasterControl

    An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.

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  • GDPR Deadline Approaches: What Is Expected for Compliance?

    3 April, 2018 by Dave Jensen, Staff Writer, MasterControl

    First the bad news. As long as health care-related data remains a valuable commodity, security breaches and data theft will persist. The good news is global regulatory agencies are ramping up their cybersecurity measures in an effort to restore relevance to the “protection” component of protected health information (PHI).

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  • What Do Changes to Australia’s PIC/S Guide to GMP Mean for Pharma Down Under?

    1 February, 2018 by Luana Carone, Solutions Consultant for Australia/New Zealand, MasterControl

    It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.

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  • 4 Ways an EQMS Can Help You Improve Supplier Visibility

    9 January, 2018 by David Butcher, Staff Writer

    Leveraging a centralized electronic quality management system (EQMS) can help medical device manufacturers bring together all quality data, leading to greater visibility and solutions to at least four key quality challenges across the extended supply chain, according to MasterControl Senior Product Manager Terrance Holbrook.

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  • 5 Most Common Pharma Form 483 Quagmires & How to Avoid Them

    26 December, 2017 by James Jardine, Staff Writer, MasterControl

    See the most common reasons the FDA cited pharmaceutical companies with Form 483 Inspectional Observations last year and examine potential remedies that can help prevent future warnings.

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  • What Is a Quality Control System and How Can an EQMS Improve On It?

    15 August, 2017 David Butcher, Staff Writer, MasterControl

    For organizations doing business in regulatory environments, successful quality assurance and quality control are crucial aspects of quality management in FDA- and ISO-regulated environments. Often, “quality control” and “quality assurance” are used interchangeably, referring to the activities conducted to ensure the quality of a product, service or process. While some quality control and quality assurance activities are interrelated, however, the two

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  • 5 Ways Artificial Intelligence Is Changing Health Care and What It Means for Quality Management

    27 December, 2016 Beth Pedersen, Marketing Communications, MasterControl

    Health care data is expected to reach a staggering 2,300 exabytes (one exabyte is equal to one billion gigabytes) in 2020. We all know knowledge is power, but the amount and complexity of data in existence has long since outpaced the human mind’s ability to access and process it. Enter artificial intelligence (AI). Since its inception over half a century ago, AI has experienced an ebb and flow of attention, investment, development and scrutiny but one idea persists: the promise of making human lives significantly better.

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  • Santa Claus Is REAL but He Requires an EQMS!

    20 December, 2016 Marci Crane

    Once upon a time your parent or some “responsible” adult decided to be a big dope and tell you that Santa Claus wasn’t real. You, always the awesome kid on the block, took the news with grace but nevertheless it carved a scar onto your tender little heart.

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  • Top 5 Medical Device Trends of 2016

    26 May, 2016 Lisa Weeks, Marketing Communications, MasterControl

    Ben Franklin said, “When you’re finished changing, you’re finished.” That’s advice medical device makers can take to heart because 2016 really is shaping up to be a year of unprecedented industry change. Non-traditional medical device companies, such as Google and Apple, are entering the space, disrupting the business models of major industry players.

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  • Compliance, Innovation and GMPs at the 32nd SQA Annual Meeting & Quality College

    4 April, 2016 Robyn Barnes, Marketing Communications, MasterControl

    If you’re not cultivating a culture of quality at your workplace, what are you doing to improve compliance, innovation and good manufacturing practices (GMPs)?

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  • 5 Tips for Winning Executive Buy-In for a New QMS

    26 May, 2015 Matthew M. Lowe, Executive Vice President, MasterControl Inc.

    If you’re facing executive or organizational resistance to your plan to automate your quality system, you’re not alone. There are many quality and IT professionals who are in the same boat. They have the toughest time convincing senior management not just about the merits of an electronic quality management system (EQMS) but about the real value of quality.

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  • 6 Ways to Ensure Your QMS Meets FDA and ISO Compliance

    19 February, 2015 David R. Butcher, Marketing Communications, MasterControl

    An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Those lacking a solid quality infrastructure are simply not equipped to face the challenges of the regulatory environment and meet the demands of a competitive market.

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  • Basics: Documenting a Real QMS

    18 December, 2014 T. Dan Nelson, Consultant

    Using ISO  parlance, a management system is designed to achieve objectives.   In the case of a quality management system (QMS), the most basic objective is to succeed by satisfying customers.  A QMS is a system designed to satisfy customers by providing them with timely, quality products and services.

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  • What Is Driving More Organizations to Plan an EQMS Adoption?

    28 October, 2014 David R. Butcher, Marketing Communications, MasterControl

    In response to increased pressure to simultaneously meet compliance, mitigate risks and improve cost savings, a growing number of organizations are taking steps to transform their quality management by adopting enterprise quality management software (EQMS). Research indicates that approximately 40 percent of companies are currently planning to implement an EQMS solution. What are the key drivers behind the rising number of companies moving toward EQMS adoption?

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  • Why Do Corrective Actions Fail?

    23 September, 2014 Ed Grounds, President Integrated Solution Providers Software, Inc.

    Each year, the most popular learning course we provide is targeted at developing the skills necessary for our customers’ associates to implement their corrective action programs effectively and efficiently. Throughout the years, we have been asked the same question hundreds of times, “What are the most common reasons corrective actions fail?” Usually this question is asked during the corrective action learning session by a management team member hoping that we will deliver the message to the other team members that they are failing. Normally, we turn the question back around to the group and ask them why they think their corrective action program fails. The most common answers we hear are: limited time, resources, training, or not knowing which tools to use.

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  • INFOGRAPHIC: Closed-Loop Quality Management and the Cost of Inaction

    11 September, 2014 David R. Butcher, Marketing Communications, MasterControl

    In today’s global manufacturing environment, continuing to rely on outdated, siloed quality management technology comes at a cost that many regulated companies simply cannot afford, new research indicates. That is why leading manufacturers are taking quality management further, leveraging EQMS to develop closed-loop quality processes that track quality throughout the value chain.

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  • Current Issues in Medical Device Risk Management

    29 July, 2014 by Edwin Bills, RAC Consultant

    Medical devices have been developed with some requirements for product safety since the implementation of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act.  Initially FDA required manufacturers to submit information related to safety as part of the 510(k) premarket notification process, providing comparative data on predicate devices versus the device under consideration.  In the more rigorous Premarket Approval (PMA) process, more detailed safety inform

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