GxP Lifeline

 

Showing items tagged as closed-loop quality management

  • Holiday Party Hosting Tip: Get an eQMS

    December 14, 2017 by David Jensen, Staff Writer, MasterControl

    It’s that time of year when we get together with family and friends and enjoy holiday festivities. Sure, all the mingling and merriment of a holiday party can be fun, but organizing an event—not so much. If you happen to be the designated planner/host of your holiday soiree, you may want to consider using an electronic quality management system (eQMS).

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  • 5 Guidelines for Writing a Useful Clinical Monitoring Report

    November 15, 2017 by Brandy Chittester, IMARC Research, Inc.

    A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight during an FDA inspection. Here are a few important guidelines you and your staff should follow to ensure your clinical monitoring reports are accurate and complete.

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  • Mayday! Mayday! These "Unknown Unknowns" Can Torpedo Your QMS

    August 19, 2016 by Walt Murray; CLA, CSSMBB ARC Experts

    In psychology, people talk about knowledge and learning in terms of four levels: what we know, what we think we know, what we know we don’t know, and what we don’t know we don’t know. In the life sciences, the fourth level, what we don’t know we don’t know (or unknown unknowns, for short), carries the most risk in quality and compliance. If you are in a leadership position, the risks are even higher. After all, how can you provide the appropriate resources or strategic direction while operating in a knowledge void?

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  • Get Products to Market Sooner by Systematizing Quality Cycles

    July 16, 2015 by James Jardine, Marketing Communications, MasterControl

    It all starts with an initial idea developed with a collaborative team. Input is gathered from all the necessary sources and then tweaks to the original concept are made as needed. Many different types of reviews, approvals, and regulatory checks are also required during this development stage. Then it’s time to provide suppliers or vendors with specific orders to ensure all the puzzle pieces will fit together as planned. Once your organization’s employees receive all the training they need to make the product according to the specifications that have been devised it feels like you’ve almost reached the finish line. Now you just flip a switch and watch as the magic is made while you celebrate your magnificent accomplishment, right?

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  • Infographic: How Evolved Is Your Quality Management System?

    March 17, 2015 Lisa Weeks, Marketing Communications, MasterControl

    Quality management systems (QMSs) have steadily evolved over time. The sophisticated systems of today are a far cry from the primitive paper-based systems of the past. They're faster, leaner, greener and just plain better. How did we get to where we are today? And is your company at the top or bottom of the QMS evolutionary chain? View the infographic, or keep reading to learn more about the evolution of the enterprise QMS.

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  • Mind The Gap: Are Training Gaps Preventing You From Closing The Quality Loop?

    November 25, 2014 Stephanie Jones, Senior Professional Services Consultant, MasterControl

    If you follow GxP Lifeline regularly, you’ll notice that we’ve been talking a lot about the concept of closed-loop quality recently, and here’s why. In the face of an increasingly competitive business environment, manufacturers are discovering that traditional approaches to quality management are no longer working (and haven’t been for quite a while). Treating compliance as a series of data or process silos that vary with department or product lifecycle stage simply won’t cut it anymore. A closed-loop approach is what’s needed today because it provides a more holistic view of product and process quality throughout the value chain as well as a considerable competitive advantage.

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