Showing items tagged as Quality

  • 5 Essentials to Effectively Manage a Quality System

    19 March, 2020 by Brian Matye, CFO, Regulatory Compliance Associates Inc.

    In the life sciences and other regulated industries, effective quality system management is essential. Companies can’t deliver a safety and effective product and comply with regulators without one. But it’s also crucial that companies take a risk-based approach to selecting and developing a quality system is well suited to their needs. Digital QMS solutions often offer unsurpassed benefits that a paper-based system can’t deliver.

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  • When Quality Met Manufacturing

    13 February, 2020 by Sarah Beale, Staff Writer, MasterControl

    It’s February, so stores are flooded with Valentine’s Day candy, flowers and greeting cards. None of these are for the quality-manufacturing relationship, but it still deserves some attention. If your quality and manufacturing departments have enough drama to give a rom-com a run for its money, it’s time to take the first step to bringing them together.

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  • Why Quality 4.0 Should Be a Top Priority for Quality Managers

    4 February, 2020 by Mike Rigert, Staff Writer, MasterControl

    As a new calendar year approaches, the technology at our disposal is exceeded only by the number of ways it can be applied to improve communication, understanding, planning and productivity. In fact, the last decade has seen such rapid advances in areas like connectivity, mobility, analytics, scalability and data that it has sparked a fourth industrial revolution, known as Industry 4.0. IT and operations teams are chomping at the bit to implement these new technologies to help them operate better, smarter and faster. But what does this mean for quality and the teams responsible for it?

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  • Quality’s Unstructured Data Dilemma: 3 Reasons to Overcome Document Dependency

    30 January, 2020 by James Jardine, Staff Writer, MasterControl

    Companies whose quality management practices are document dependent are neglecting the insights trapped in their quality data. Learn about the promise and peril of unstructured data and how connectivity can unlock your quality function’s potential.

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  • 5 Ways to Prepare for the Future of Quality Now

    4 December, 2019 by Sarah Beale, Staff Writer, MasterControl

    The future of quality is closer than you might think, and the time to prepare is now. During the 2019 Masters Summit, MasterControl Partner KPMG presented a session on the future of quality and how it can help the life sciences industries now.

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  • World Quality Day 2019: Celebrating the Past, Present and Future of Quality

    14 November, 2019 by Beth Pedersen, Staff Writer, MasterControl

    Have you ever thought about what quality means to you? It may mean something different to everyone, but its power to change lives for the better unites people around the world. On World Quality Day, we celebrate this uniquely human concept and the impactful work of quality professionals everywhere by taking a moment to reflect on the past, present and future of quality.

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  • WD-40 Company Tells Why Quality Is Priority No. 1

    5 September, 2019 by David Jensen, Staff Writer, MasterControl

    WD-40 has been silencing squeaks and vanquishing rust and corrosion all over the world since 1953. This success story can be attributed to the product’s secret formula. To the company’s employees, the product's legacy is largely due to effective quality management. In a new video, several WD-40 Company team members tell how quality is the company’s number one priority.

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  • 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?

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  • 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.

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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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  • 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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  • 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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  • Executive Perspective: Why Paperless Batch Records Make (Dollars and) Sense for Wellington Foods

    20 February, 2019 by Beth Pedersen, Staff Writer, MasterControl

    Manufacturers across all industries continue to implement and expand their digital transformation strategies, and as a result, the presence of paper on the factory floor is in decline. But one critical production process is proving to be more dependent on paper than others – at least until now. With the help of an innovative new solution, contract manufacturer Wellington Foods is one of the first companies to fully digitize its batch record process, and it’s already reaping the benefits.

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  • Top 4 Manufacturing Trends Impacting the Batch Record Process in 2019

    5 February, 2019 by Beth Pedersen, Staff Writer, MasterControl

    Technology is changing the way we do everything, and pharmaceutical manufacturing is no exception. A new MasterControl white paper discusses the tech trends pharma manufacturers should prepare for in 2019, particularly as they relate to the business-critical – and notoriously inefficient – batch record process.

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  • Champagne: A Staple of Celebration; A Legacy of Quality

    27 December, 2018 by David Jensen, Staff Writer, MasterControl

    Champagne has long been a staple of holidays and momentous occasions. The bubbly beverage is also deeply rooted in culture and tradition. To coincide with the mirth and merriment of the holiday season, this article discusses the rich history of Champagne and how it has become synonymous with quality.

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  • Building an Audit-Ready QMS

    15 November, 2018 by Joy McElroy, Consultant and Business Development Director, Maynard Consulting Company

    Consumers and patients assume manufactured pharmaceuticals are safe and effective. In order for quality units to assure this, you have to have a robust quality control (QC) and quality assurance (QA) program guided by an equally sound quality management system (QMS). Learn the roles of QC and QA and how to create a QMS that will help your company maintain a high level of quality.

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  • FMEA Without Tears: A Prescription to Reduce Pain and Confusion

    11 October, 2018 by Rai Chowdhary, CEO and Founder, The KPI System

    Failure modes and effects analysis (FMEA) is a particularly effective tool in risk management. But its use is often accompanied by fear or pain because practitioners struggle to apply it. Learn how to effectively use FMEA without trepidation to improve your company’s risk management operations.

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  • Airplane Preflight Check Exemplifies Quality in Med Device Design

    10 October, 2018 by David Jensen, Staff Writer, MasterControl

    Before any aircraft leaves the ground, it undergoes a preflight check. Part 2 of this series on BraveHeart features Steve McCalmont performing an aircraft preflight check to illustrate how this critical part of flying equates to the importance of incorporating quality in the design of a medical device.

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  • Using a QMS to Qualify Your Suppliers

    2 August, 2018 by Sarah Beale, Staff Writer, MasterControl

    Adulterated supplements and adverse events have long been the bane of the nutraceutical industry. However, this shouldn’t and doesn’t have to be the norm. By qualifying suppliers or ingredients, nutraceutical companies not only comply with CGMPs, they also protect their customers.

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