Showing items tagged as Quality

  • An Expert Explains Data Integrity and Organizational Excellence – Part Two

    October 1, 2020 By Dale Thompson, Staff Writer

    Data integrity is an integral part of organizational excellence. An expert explains why companies need to align their efforts with customer needs, one of which is adhering to all applicable regulations. Common mistakes around 21 CFR Part 11 are explored along with ways to avoid them.

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  • What Connected Quality Means for Training

    September 9, 2020 by Sarah Beale, Staff Writer

    For regulated companies, there’s a lot riding on training. If someone isn’t trained, the life-saving products of life sciences companies can become life-ending products. An integrated training management system gives training managers a complete picture of what’s going on with training and what they need to do next to stay on track.

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  • Quality Audit—A Tool for Continuous Improvement and Compliance

    September 4, 2020 By Jason Clegg, Director, Marketing Strategy

    Audits are essential to regulated industries. The type of audit, who conducts it, and which regulations and standards are involved are all important. The process has its own challenges which have only been exacerbated in the current environment.

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  • The Fundamentals of Immunization, Part 2

    September 3, 2020 By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA

    The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. This is the second of a three-part series on the fundamentals of immunization.

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  • Top 4 Reasons Why Documentation Reviews Are Critical to Compliance

    August 20, 2020 David Butcher, Staff Writer

    When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.

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  • How to Shift From Proactive to Predictive Quality Data Management

    August 11, 2020 by James Jardine, Staff Writer

    The reluctance to abandon conventional paper-based quality management systems (QMS) has long typified the life sciences industry’s approach to quality. Familiar yet inefficient quality models are shortsighted, however.

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  • SPC vs SQC: The Strategic Difference

    July 17, 2020 By Jason Orloff, Statistical & Engineering Consultant, Pharmstat

    The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).

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  • Our Expert Weighs in on Platforms, Data and AI

    July 16, 2020 by Sarah Beale, Staff Writer, MasterControl

    MasterControl Product Management Director Sue Marchant sat down with GxP Lifeline to talk about our platform approach, why that’s important and how it can eventually lead to artificial intelligence (AI) applications for our customers. She also gave us a sneak peek at what to expect in the next generation of MasterControl products.

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  • Four 2019 Manufacturing Batch Record Trends Holding Up in 2020

    July 10, 2020 Dale Thompson, Staff Writer, MasterControl

    Manufacturing batch record trends from 2019 have picked up speed in 2020. Now is the time to focus on becoming data-centric, move to digital batch records, utilize the potential of workers on the shop floor, and create a truly paperless manufacturing environment.

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  • Overcoming Minimalism to Elevate Manufacturing Quality

    May 27, 2020 by Jim Leonard, Senior Consultant, QSG

    The philosophy and cultural of minimalism and “settling” can be disadvantageous when it comes to quality manufacturing standards and expectations. Jim Leonard, a senior consultant with QSG, presents quantitative and qualitative analysis of how such approaches can stagnate quality and shares tips on how to achieve a high level of continuous improvement in manufacturing.

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  • 3 Main Barriers to Connected Quality and How to Overcome Them

    April 21, 2020 by James Jardine, Staff Writer, Master Control

    Shrinking margins, intensifying competition and rapidly increasing product personalization and customization are complicating new product introduction pipelines in the life sciences. Leveraging the data connectivity capabilities of platforms is the key to overcoming these and other obstructions to a connected quality life cycle.

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  • 5 Essentials to Effectively Manage a Quality System

    March 19, 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 safe 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 that's 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

    February 13, 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

    February 4, 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

    January 30, 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

    December 4, 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

    November 14, 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

    September 5, 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

    July 18, 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

    July 3, 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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