• A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences

    12 May, 2015 ames Jardine, Marketing Communications, MasterControl

    Increasingly strict regulatory measures are drawing attention to the inadequacy of the systems and processes life sciences companies use to manage quality and production. A new eBook from LNS Research entitled A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences outlines some of the major challenges faced by life sciences companies and shows how prominent organizations are successfully handling those difficulties.

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  • 3 Keys to Driving Collaborative Growth in Life Sciences

    26 March, 2015 James Jardine, MasterControl

    A recent study by LNS Research shows that life sciences companies are facing an unprecedented demand for better and safer products. Results from LNS Research’s surveys of industry executives indicate the pressures life science organizations are facing and the new technologies and processes they are employing to meet rising needs.

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  • 6 Ways to Ensure Your QMS Meets FDA and ISO Compliance

    19 February, 2015 David R. Butcher, Marketing Communications, MasterControl

    An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Those lacking a solid quality infrastructure are simply not equipped to face the challenges of the regulatory environment and meet the demands of a competitive market.

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  • The Perks of Pursuing a Career in Quality Management

    17 February, 2015 Greg Peckford, Founder, Quality Career Advancement

    It is a bit of a mystery to me that more is not made of the personal career advantages and knowledge gained from performing procedural assessments, audits and other quality management related functions. For me personally, this type of activity has been one of the key factors in my career progression and advancement.

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  • Getting Ready for ISO 13485:201X (Part 1)

    22 January, 2015 Lisa Weeks, Marketing Communications

    As most of you know, ISO 13485–Quality Management Systems—Requirements for Regulatory Purposes is being revised. ISO 13485:201X, as the final revision is being referred to, is expected to be available in late 2015 or early 2016. Understandably, this is causing anxiety for medical device manufacturers, many of whom are still struggling to conform to the current version of the standard. With this in mind, let’s review the basics of the ISO: 13485. In future posts, we’ll examine why the standard is being updated, and the most significant changes you can expect to see.

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

    13 January, 2015 Laurie Meehan, Internal Project Manager, Polaris Compliance Consultants, Inc.

    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.

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  • Basics: Documenting a Real QMS

    18 December, 2014 T. Dan Nelson, Consultant

    Using ISO  parlance, a management system is designed to achieve objectives.   In the case of a quality management system (QMS), the most basic objective is to succeed by satisfying customers.  A QMS is a system designed to satisfy customers by providing them with timely, quality products and services.

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  • MasterControl Continues Role as QMS Provider for FDA’s Office of Regulatory Affairs

    13 November, 2014 Cindy Fazzi, Editor, MasterControl Insider

    The U.S. Food and Drug Administration (FDA) has been protecting American consumers for over 100 years. In the face of increasing global interdependence, the FDA’s responsibility has expanded by necessity; it works with its counterparts throughout the world to help ensure product safety and quality.

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