• FDA Eager to be Innovative Partner with Expedited Access Pathway

    16 March, 2017 David Jensen, Staff Writer, MasterControl

    Part of FDA’s prime directive is to assure the safety, effectiveness and quality of biological products and medical devices. So the notion of FDA endorsing the acceleration of product development might raise some eyebrows. However, FDA officials and industry experts alike seem to agree that with some patients waiting is not the hardest part, it’s actually not an option.

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  • 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 ….

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  • FDA Guidance Answers Questions Regarding Data Integrity

    23 March, 2017 by David Jensen, Staff Writer, MasterControl

    An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “

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  • When You Find Yourself Between a Rock and a Hard Place

    27 March, 2017 Beth Pedersen, Staff Writer, MasterControl

    We all have those days where everything that can go wrong, does. Where it seems the entire universe is working against you, testing your patience, your determination and your will to carry on. But in the scheme of things, are these so-called bad days really

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  • 5 Warning Signs of Diminishing Supplier Quality

    30 March, 2017 David Butcher, Staff Writer, MasterControl

    supplier’s quality system doing what it’s supposed to be doing? Would you know if it weren’t? How would you know if there were flaws in your supplier’s quality processes before the problems get worse? These are the questions MasterControl’s Terrance Holbrook attempts to answer for medical device manufacturers in a recently published post on MDDI’s Device Talk blog.

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  • How to Practice Quality Management in Your Personal Life

    4 April, 2017 Paul Sanderson, Solutions Consultants Manager, MasterControl

    “Quality management” is one of those terms that sounds so simple and esoteric at the same time, like DNA or free cash flow. I’m pretty sure I know what those terms mean until I start explaining them to someone. 

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  • 4 Rules for Building an eClinical Qualification Framework

    6 April, 2017 by Rob Sims, Marketing Programs Manager, UL

    As clinical trials continue to expand globally, technology plays a critical role in maintaining data integrity and at the same time accelerating study start-up. Consider a study management team that must travel globally to hold investigator meetings. Travel now takes up a much greater portion of the study management team’s time and energy.  That’s why study teams have turned to eClinical technology to reduce this effort – from preclinical R&D and regulatory communication to packaging/di

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  • Top 5 Takeaways from MedTech Intelligence’s Medical Device Cybersecurity Conference

    11 April, 2017 David Jensen, Staff Writer, MasterControl

    I recently attended a conference on Medical Device Cybersecurity hosted by MedTech Intelligence held March 23-24, in Washington, DC. It’s evident that cybersecurity is an important concept as attendance, both in-person and remote, was high. Conference organizers lined up a powerhouse group of presenters who are all entrenched in the technology, cybersecurity, legal and regulatory compliance industries.

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  • Site Selection: Don’t Forget About the Study Drug

    13 April, 2017 by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and timeframes, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient data

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  • Human Factors: Why it is Critical in Designing Medical Devices

    18 April, 2017 David Jensen, Staff Writer, MasterControl

    “Most of the time spent wrestling with technologies that don’t quite work yet is just not worth it for end users, however much fun it is for nerds.” 

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  • What Do Food Facility Auditors Really Want? A Practical Guide to Reducing Your Audit Stress Level

    20 April, 2017 by Bryan Armentrout , CEO, The Food Leadership Group

    Third party audits are critically important to food companies. They are the primary tool your customers use to determine if adequate food safety systems are in place. This article covers some of the strategies and tactics you should employ to maximize your chances of a successful audit.

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  • 20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    24 April, 2017 Cindy Fazzi, Staff Writer, MasterControl

    If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

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  • "We're Different!" Overcoming the Challenges of Applying Lean Principles to Knowledge Work

    27 April, 2017 by Drew Locher, President, Change Management Associates

    If you are applying lean management principles to R and D, life science, or other knowledge work processes, you’ve probably heard the "we're different” argument. It usually goes something like this, “You can’t apply lean process improvement techniques to creative work because everything we do varies."

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  • 10 Criteria to Aid in the Selection of Investigative Sites

    2 May, 2017 by Craig Morgan, Head of Marketing, goBalto

    Investigative sites are the heart and soul of clinical trials, essential to ensuring the efficacy and safety of pharmaceutical compounds in humans. Site selection is pivotal to the successful execution of trials, which are not only long and bureaucratic, but are also experiencing diminishing returns. Studies estimate that it costs upwards of $2B dollars to bring a new drug to market, with daily revenue losses in ranging from $1M to $8M due to delayed market entry.

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  • Life Science Polls Reveal Lack of Automation, High Cost of Quality Stoppages

    4 May, 2017 Cindy Fazzi, Staff Writer, MasterControl

    Increased automation through digital technology platforms is one of the top business trends for 2017 (1). It’s a crucial enabler for businesses to compete successfully, according to the IT research and advisory company Gartner Inc.

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  • What is a Document Management System and 8 Reasons Your Company Probably Needs One

    9 May, 2017 Marci Crane, Staff Writer, MasterControl

    A document management system is a software solution that allows for the digital management of documentation. Today most documentation managed by document management systems is business-related.

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  • What Is a Document Control System?

    12 May, 2017 David Jensen, Staff Writer, MasterControl

    Being in the regulated manufacturer arena, you have heard that oft recited phrase “if it isn’t documented, it didn’t happen.” This motto shared among life sciences companies means an efficient document control system is at the core of quality management. Documents and records serve as proof that your company follows good manufacturing and document management practices required for compliance.

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  • The “New Normal” for FDA Enforcement of the Food Industry: What You Need to Know and How to Prepare

    16 May, 2017 by Maile Gradison Hermida and Brian D. Eyink, Hogan Lovells US LLP

    With the parade of headlines announcing a new food-borne illness investigation, recall, or Food and Drug Administration (FDA) enforcement action continuing unabated, food company executives, quality assurance officers, and legal counsel are struggling to understand the new food enforcement paradigm.  Although every situation and company is different, in this article we identify four key developments that all food companies need to be aware of, as well as key steps that will help to prepare

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  • Keeping Up With the Top Pharma Industry Trends of 2017

    18 May, 2017 James Jardine, Staff Writer, MasterControl

    A close look at the key trends that will have the biggest impact on the pharmaceutical industry this year.

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  • The 15 Strangest Phobias and Why They Include the Fear of Paper

    23 May, 2017 Marci Crane, Staff Writer, MasterControl

    It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.

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