Showing items tagged as Quality

  • Virtual Masters Summit 2020: Digital Transformation and Data in a Time of Uncertainty

    January 5, 2021 By David Butcher, Staff Writer

    Every organization is dealing with a deluge of data and the challenges of uncertainty. Companies are drowning in data but starving for insights in a time of rapid change, both domestically and globally. What’s needed is the ability to easily access, analyze and apply data in real-time to current challenges, while using the information to better plan for and shape the future. At Virtual Masters Summit 2020, two thought leaders highlighted ways that emerging technology and data can help life sciences organizations move forward during uncertain times.

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  • Five Best Practices for Ensuring Supplier Quality

    December 21, 2020 By David Jensen, Staff Writer, MasterControl

    Managing various suppliers is complicated. Lapses in process or product quality along the supply chain can have a negative impact on the end product. This article includes five best practices for establishing more effective oversight of suppliers throughout the supply chain.

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  • Three Quality Management Trends to Watch in 2021

    December 15, 2020 By Richard Goeb, Quality Team Member, Cannon Quality Group

    Three key trends in MedTech quality management for 2021 include a rise in eQMS adoption, the continuation of remote audits and an increase in shared supplier audits.

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  • Quality Assurance, Quality Control and Quality Management: Clarifying Confusion

    December 4, 2020 By James Jardine, Staff Writer

    With so many similar sounding terms related to quality in life sciences manufacturing, it’s easy to get confused about their definitions and intersections. Learn the purposes of quality assurance, quality control and quality management, their overlap and the differences between each critical function.

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  • Looking to Adopt Technology? Look at Processes First

    December 1, 2020 By Dale Thompson

    Managing Consultant for Enterey, John Chiechi, explains that before adopting new technology, a business must have the right processes in place.

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  • What Is Pharmaceutical Quality by Design?

    November 24, 2020 by Beth Pedersen, Technical Writer, MasterControl

    Approximately one out of every 10 drug products make it to market. Pharma companies are striving to improve that statistic by implementing more effective quality and risk management measures. Quality by Design (QbD) is one of those measures and it’s becoming more widely adopted by manufacturers in the life sciences industry.

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  • The Fundamentals of Immunization, Part 3

    November 17, 2020 By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA

    Learn about the leading candidates in the race for safe and effective COVID-19 vaccines and therapeutics, as well as the technologies being utilized to shepherd us to the end of this pandemic.

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  • What Connected Quality Means for Training

    November 12, 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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  • Celebrating Quality Mastery (and Mishaps) on World Quality Day

    November 12, 2020 By James Jardine, Staff Writer

    World Quality Day 2020 provides the ideal opportunity to celebrate quality professionals who go above and beyond. It’s also a good time to have some LOLs about the quality world’s more comical and cringeworthy experiences. Giggle (or groan) along with the entries in the Quality Shorts Film Fest, and find out who won the 2020 Masters of Excellence Awards.

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  • Give Thanks for Better Document Control

    November 10, 2020 By Sarah Beale

    There are multiple things that make Thanksgiving stressful. Relatives and food immediately come to mind. The level of orchestration required to pull off a successful Thanksgiving dinner is ridiculous. While we can’t make it easier to manage a successful Thanksgiving, there are ways to simplify your document management using artificial intelligence (AI) and advanced analytics.

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  • Quality Agreements With Contract Manufacturing Organizations (CMOs)

    October 9, 2020 By James Jardine, Staff Writer

    Life sciences companies are growing increasingly reliant on contract manufacturing partners as they strive to compete in a fast-paced and continually evolving industry. From the FDA’s perspective, those partnerships mean that both product owners and their contract facilities are responsible for CGMP compliance. Learn how quality agreements help both parties cover all their compliance bases.

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  • Using Connected Quality to Track Down Problems

    October 7, 2020 By Sarah Beale

    Mistakes are inevitable in any process. The problem is making sure those mistakes aren’t repeated and that any underlying issues are resolved. To do this, you need good systems in place for detecting problems, the severity of problems, determining a solution, and implementing that solution.

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  • 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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  • 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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