background image for GxP Lifeline
GxP Lifeline

Showing items tagged as quality management system

  • Differences between Quality Assurance, Quality Control and Quality Management for Life Sciences Manufacturing.

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

    There are so many similar terms related to quality in the life sciences, it’s easy to get confused about their purposes and intersections. Learn the specific roles of quality assurance, quality control, and quality management, how they overlap, and the differences between each critical function.

    Full story
  • MasterControl’s Medical device QMS can help comply with medical device quality regulations.

    4 Ways to Prepare for UK Medical Device Regulations (MDRs)

    The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) recently issued new guidance pertaining to regulated medical devices in the UK. Here’s how to prepare.

    Full story
  • 2021-bl-eifu-impact-on-qms_132x132

    The Impact of Implementing an eIFU Solution on Your Quality Management System

    Electronic instructions for use (eIFU) are just as compliant as paper ones, but any implementation of a new system is going to affect existing ones. In particular, the quality management system (QMS) will need to be updated in certain areas to prepare for the switch.

    Full story
  • 2021-bl-fagron-new-expanded-case-study_132x132

    Fagron’s Key to Quality Alignment: Extending QMS Capabilities

    Global pharmaceutical compounder Fagron is closing in on its goal to align quality across 66 sites worldwide. Discover how expanding the use of its cloud-based quality management system (QMS) to more business units is turning the company’s quality dreams into reality.

    Full story
  • 2021-bl-career-in-quality-management_132x132

    Pursuing a Career in Quality Q&A — Part 1

    The quality management career path isn’t as straightforward as getting a bachelor’s in quality management, which can be problematic if you’re considering a career in quality. That’s why we sat down with a quality expert to find out how to start a career in quality and what that looks like on a day-to-day basis.

    Full story
  • 2020-bl-future-trends-opportunities_132x132

    Future Trends and Opportunities in Quality Assurance

    At a previous PDA/FDA Joint Regulatory Conference in Washington, D.C, Donna Gulbinski, quality and regulatory affairs expert, provided useful information about the future of quality management. She identified some key strategies for how your organization can identify and understand quality assurance trends and develop initiatives for long-term success.

    Full story
  • 2019-bl-thumb-3-critical-keys-integrated-management

    3 Keys to Implement an Integrated Management System With ISO 9001

    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.

    Full story
  • 2018-bl-thumb-creating-an-audit-ready-qms

    Building an Audit-Ready QMS

    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
  • 2018-bl-thumb-top-5-med-device-industry-trends-software complex

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

    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
  • 2017-bl-author-wolfgang-schmitt

    How to Become a QP in Europe

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

    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
  • abstract-digital-document-icon-132

    GCP Compliance: Eliminating Silos between Clinical Quality and Clinical Operations

    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
  • ISO 13485:2016 What are the Changes About?

    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
  • What Does Risk-Based Monitoring Mean for QA Auditing?

    By now, we all know that risk-based monitoring (RBM) isn’t just about changing the role of the clinical research associate (CRA); it’s transforming the way clinical studies are managed. So what does that mean for quality assurance (QA) teams who audit these new processes? Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.

    Full story
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]