• 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
  • 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
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • Using the Newly-Approved Dietary Fibers in Supplements

    19 July, 2018 by Sarah Beale, Staff Writer, MasterControl

    Many consumers don't get enough fiber, leading to health problems that are especially prevalent as people get older. Fiber supplements can help fill the gap, and now the FDA has expanded its definition of dietary fiber to include eight more sources.

    Full story
  • Is Supplier Quality a Fallacy? Implement Risk-Based Control in Design

    3 July, 2018 by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting

    Medical device manufacturers must rely on more than their buyers or procurement group to provide supply quality. In order to be successful, companies must implement risk-based design controls in order to minimize risk and maximize benefits to their supply quality process.

    Full story
  • What Biotech Startups Need to Do to Slay the Competition

    21 June, 2018 by Matthew M. Lowe, Executive Vice President of MasterControl

    Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

    Full story
  • Time Management: Walk the Talk, QA Professionals!

    12 June, 2018 by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting

    Quality assurance professionals are experts when it comes to talking about time management. But how to they fare in practice? Find out in this month's Quality Manager Tip by Walt Murray.

    Full story
  • 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.

    Full story