Showing items tagged as quality management system

  • 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
  • Expert Tips on Enhancing CAPA Through Innovation

    2 October, 2018 by James Jardine, Staff Writer, MasterControl

    This examination of quality guru Ken Peterson’s proven corrective and preventive action (CAPA) innovation techniques provides strategies and sequential principles for refining transformative CAPA innovations, avoiding half-baked solutions and obtaining organizational buy-in of revolutionary quality event management ideas.

    Full story
  • Leveraging the Value of Quality in Your Business Through ISO

    11 September, 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.

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

    21 August, 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.

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

    9 August, 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.

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

    1 February, 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.

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

    26 October, 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?

    Full story
  • How to Become a QP in Europe

    24 October, 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?

    Full story
  • Future Trends and Opportunities in Quality Assurance

    19 October, 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.

    Full story
  • ISO, Regulatory Requirement Changes Loom

    1 September, 2017 by 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:

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

    21 March, 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 ….

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

    29 November, 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!”

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

    2 August, 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.

    Full story
  • ISO 13485:2016 What are the Changes About?

    3 March, 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.

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

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

    How to Ensure You are Following the ISO 9001 Certification Process

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

    29 December, 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.

    Full story
  • Holistic CQMS: The Modern Model of Clinical Trial Management

    23 November, 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.

    Full story
  • What Do You Do? A Short and a Long Answer

    29 September, 2015 Jon Beckstrand, MasterControl CEO

    I was recently asked point-blank: What does MasterControl do? I was being interviewed for a medical device publication’s podcast, so the question was expected. Still, it forced me to mull over the company’s mission and accomplishments in the past 13 years under my leadership.

    Full story
  • It’s Hot in Here—Quality, Compliance, and Romance

    8 July, 2015 Cindy Fazzi, Editor, MasterControl Insider

    Sun, spice, and romance—they’re everything I associate with summer. And I’m not talking about your love life, but your quality system. Indulge me for a moment and let me talk about the two things—quality software and romance—that preoccupy me most. I’m a full-time marketing writer and a newly published romance author. By day, I write about quality and compliance. By night, I write about people who live happily ever after (known as HEA to romance readers).

    Full story
  • 5 Tips for Winning Executive Buy-In for a New QMS

    26 May, 2015 Matthew M. Lowe, Executive Vice President, MasterControl Inc.

    If you’re facing executive or organizational resistance to your plan to automate your quality system, you’re not alone. There are many quality and IT professionals who are in the same boat. They have the toughest time convincing senior management not just about the merits of an electronic quality management system (EQMS) but about the real value of quality.

    Full story

 

Browse by Industry

General Manufacturing 8 Medical Device 214 Nutraceuticals 10 Pharma 197 Quality 190