• Current Issues in Medical Device Risk Management

    29 July, 2014 by Edwin Bills, RAC Consultant

    Medical devices have been developed with some requirements for product safety since the implementation of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act.  Initially FDA required manufacturers to submit information related to safety as part of the 510(k) premarket notification process, providing comparative data on predicate devices versus the device under consideration.  In the more rigorous Premarket Approval (PMA) process, more detailed safety inform

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  • Industry Expertise Sets MasterControl Apart from Competition

    19 August, 2014 by James Jardine, Marketing Communications, MasterControl

    Over the past two decades, MasterControl has flourished to become one of the world’s foremost providers of quality management software solutions and services. But innovative technology is not the only driver behind the QMS leader’s prosperity. In fact, it is the industry experience of MasterControl’s knowledgeable personnel that is the guiding force that propels the company’s continued growth worldwide.

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  • 6 Best Practices for Enterprise Solutions Implementation

    9 September, 2014 Kevin Ash, Senior Vice President of Services, MasterControl

    Investing in a powerful software solution can be extraordinarily valuable to your organization, yet the effort is wasted if it is not implemented effectively. To help ensure a smooth and successful implementation process, consider these six best practices.

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  • Get Products to Market Sooner by Systematizing Quality Cycles

    16 July, 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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  • 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!”

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  • 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.

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