Showing items tagged as quality management system

  • Nelson Labs on Adaptability and Communication in the Time of COVID-19

    July 15, 2020 by David Butcher, Staff Writer

    Nelson Laboratories, a global provider of microbiological and analytical laboratory testing, is one of the many companies making an impact in the protective barriers area during the pandemic. The Salt Lake City-based company is heavily involved in testing the efficacy of facemasks and respirators. In a recent interview, Nelson Labs President Jeffrey R. Nelson spoke on what it has taken to achieve 24/7 coverage while maintaining quality and protecting employee health.

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  • 8 System Requirements for Extending Quality Across Expanding Ecosystems

    March 24, 2020 by James Jardine, Staff Writer, MasterControl

    More and more life sciences companies are adopting asset-light models that heavily rely on a broad system of contract organizations. When supply chains expand, however, quality is often the first casualty. Learn the key questions to ask to ensure your system can enforce quality across the entire ecosystem.

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  • 3 Keys to Implement an Integrated Management System With ISO 9001

    December 31, 2019 by Christine Park, Founder and Owner, Christine Park and Associates

    Life sciences companies that implement an integrated management system (IMS) can provide both improved compliance with ISO 9001:2015 while also better aligning your organization’s quality system and business model. Learn how to harmonize your systems.

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  • Building an Audit-Ready QMS

    November 15, 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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  • Leveraging the Value of Quality in Your Business Through ISO

    September 11, 2018 by Christine Park, Founder and Owner, Christine Park and Associates

    Rather than viewing ISO as a burden, think of it as a standard upon which you can build a foundation for the sustainability and growth of your business. Learn how to use ISO as a catalyst to align a quality management system (QMS) with the strategic direction of your company.

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  • Artificial Intelligence: Is It on the Cusp of Revolutionizing Pharmaceuticals?

    August 21, 2018 by Mike Rigert, Staff Writer, MasterControl

    One of the major technological trends beginning to impact the pharmaceutical industry is artificial intelligence (AI). Analysts say it isn’t a matter of if but when AI will become a game-changer for pharma companies, particularly when it comes to slashing the time and costs involved with drug discovery. Find out what your company can do to best plan for AI’s anticipated revolutionary impact on drug development.

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  • Top 5 Medical Device Industry Trends in 2018: Software Is More Common and Complex

    August 9, 2018 by David Jensen, Staff Writer, MasterControl

    The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.

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

    February 1, 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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  • QA vs. QC, Quality Control vs. Quality Management: What’s the Difference?

    October 26, 2017 by Kimberlee A. Washburn, Regulatory Affairs Author

    In a company organized properly, quality assurance resides independent of manufacturing and operations, and quality control resides within manufacturing and operations. But what is the difference?

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  • How to Become a QP in Europe

    October 24, 2017 by Wolfgang Schmitt, Director Operations. Concept Heidelberg

    Both the European Compliance Academy (ECA) and the European Qualified Person association (EQPA) are often contacted by people who would like to become a Qualified Person (QP according the EU Directives) outside of the EU. Is this possible?

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  • Future Trends and Opportunities in Quality Assurance

    October 19, 2017 by David Jensen, Staff Writer, MasterControl

    It’s impossible to know exactly what future trends will influence the direction and methodologies of quality assurance (QA). However, according to Bristol Myers Squibb executive Donna Gulbrinski, looking at how quality professionals overcome current challenges can lend some insight on future QA strategies and processes.

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  • ISO, Regulatory Requirement Changes Loom

    September 1, 2017 B. Christine Park, Consultant, Christine Park & Associates

    As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes.  Here are a few of the recent changes:

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  • The Most Important Four-Letter Words in ISO 9001:2015

    March 21, 2017 by Christine Park, Consultant, Christine Park & Associates

    Most organizations are well under way with the transition to the new ISO 9001:2015.  As such you should be very familiar with the emphasis on two four-letter words found throughout the document ….

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  • GCP Compliance: Eliminating Silos between Clinical Quality and Clinical Operations

    November 29, 2016 Patricia Santos-Serrao

    In a classic episode of Seinfeld, George Costanza is terrified of the potential ramifications of his “worlds colliding” when his fiancée, Susan, becomes friendlier with his dubious pals Elaine, Kramer and Jerry. “Everybody knows you’ve got to keep your worlds apart,” George rants (but when does George not rant?) “If Susan is allowed to infiltrate this world then George Costanza as you know him ceases to exist. If Relationship George walks through this door, he will kill Independent George! A George divided against itself cannot stand!”

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  • The Most Treacherous Evil Villains and the Software They Won’t Let You Buy!

    August 2, 2016 MasterControl

    Villains, like their heroic counterparts, have interesting and complex pasts. Their complexity can be strange at times and is often hard to comprehend. After all, they generally want to kill pretty much every living creature and that can be somewhat uncomfortable for “normal” humans to process. However, taking a look at a villain’s back story and his recurring behavior can help average human beings understand why villains are constantly trying to destroy love, joy, beauty and oh yes, that professional software you’re about to purchase.

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  • ISO 13485:2016 What are the Changes About?

    March 3, 2016 Linda Chatwin, Esq, RAC Manager Medical Regulatory Advisory Services, North America UL LLC

    ISO had published the final draft of the latest ISO 13485 quality management standard for medical devices, and placed it out for voting on October 29, 2015. After a two-month approval voting period, the standard was approved for official publication. For background, once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed, and only negative comments with well-reasoned, technical justification would be considered. Each technical reason is addressed in a comments resolution meeting, so that the parties resolve issues before the standard is published.

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  • How to Ensure You are Following the ISO 9001 Certification Process

    January 7, 2016 Stuart Patch, Content Writer, Compass Assurance Services

    How to Ensure You are Following the ISO 9001 Certification Process

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  • 5 Lessons I Learned from a Successful ISO 9001:2015 Certification Audit

    December 29, 2015 Lillian Erickson, Global Quality Manager, MasterControl Inc.

    The publication of ISO 9001:2015 in September generated much anxiety among companies fearing a bumpy transition to the new and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.

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  • Holistic CQMS: The Modern Model of Clinical Trial Management

    November 23, 2015 James Jardine, Marketing Communications, MasterControl Inc.

    The life science industry is experiencing a transformation in the clinical trial management paradigm. The timeworn clinical trial management system (CTMS) archetype is being increasingly supplanted by a more comprehensive and efficient clinical quality management system (CQMS) model.

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