• Setting an Organization's Risk Management Context

    15 January, 2015 Rod Farrar, Director, Paladin Risk Management Services

    There is considerable confusion in the risk world in relation to terms such as risk appetite, risk tolerance, risk acceptance, risk threshold and risk attitude (just to name a few).  These are defined differently by organisations and there is no guidance in ISO 31000 that clarifies this, so the confusion becomes a distraction.

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  • FDA Audit Practices: the 10 Most Commonly Cited Drug GMP Deficiencies of 2012-2013

    10 February, 2015 Ken Christie COO, VTS Consultants, Inc.

    If there is one word within the life science industries that causes concern and anguish it is “audit.” As with any evaluation process, the success of getting through a regulatory audit is a combination of preparedness with regards to what to expect, knowing the current regulations that apply to your product and knowing what tends to be the areas of deficiencies in audits performed. All of these items can be researched on the web and the time and effort to review and provide training on them will serve companies well.

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  • Success By the Numbers (or Why Being Science-y is a Good Thing)

    12 February, 2015 Craig Gygi, Executive Vice President, Operations MasterControl

    How do you know if you know? In other words, how do you know when you have sufficient knowledge to reliably manage or improve a process? This last question reveals the foundation of all quality, regulatory, and compliance work.

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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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  • After Five Years, Compliance-First Approach is Still Obstacle to Improving Product Quality

    3 March, 2015 Dan Matlis, Founder and President, Axendia

    Five years ago we looked at the road blocks to improving product quality.  In the intervening years there has been little change by most Med-Tech Companies.  The matter of Product Quality vs. Compliance recently has been given a push toward the Quality side by efforts made by the FDA.  The four-part whitepaper reveals how aligning process improvement initiatives with technology platforms and an integrated approached to product quality can help Med-Tech organizations improve produc

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  • Data Integrity Starts With User Access

    10 March, 2015 Jamie Colgin, Colgin Consulting

    In my next few blog posts, we'll be covering user access and how it can impact data integrity. For starters, let's explore the Principle of Least Privilege. What is it?  What happens when it's violated? Finally we'll map out five actions you can take to protect your company.

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  • Closed-Loop Quality Management: Connecting the Value Chain

    24 March, 2015 James Jardine, Marketing Communication, MasterControl

    An increasing number of leading organizations are learning that quality management must extend far beyond the manufacturing environment, according to a recent eBook co-sponsored by LNS Research and MasterControl. The research collected in the eBook indicates that market leaders are beginning to implement a closed-loop approach to quality that bi-directionally unites people, processes, and data across the value chain. This approach connects quality from design and procurement stages all the way through manufacturing and service. Other findings in the book show that Enterprise Quality Management Software (EQMS) is vital to the establishment of an effective closed-loop system that can help a manufacturer better control costs, compliance, and risk.

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  • Risk: 2015’s Most Valuable Player?

    23 April, 2015 Marci Crane, Marketing Communications, MasterControl

    For quality professionals, and especially those in quality management, there are often quality themes that seem to emerge from year to year. In 2000, the theme of process-driven quality was certainly salient and other various themes--though not necessarily new to quality management—seem to stand out as each year passes.

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  • 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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  • It’s Hot in Here—Quality, Compliance, and Romance

    8 July, 2015 Cindy Fazzi, Editor, MasterControl Insider

    Sun, spice, and romance—they’re everything I associate with summer. And I’m not talking about your love life, but your quality system. Indulge me for a moment and let me talk about the two things—quality software and romance—that preoccupy me most. I’m a full-time marketing writer and a newly published romance author. By day, I write about quality and compliance. By night, I write about people who live happily ever after (known as HEA to romance readers).

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  • Ensuring Proper Training for Clinical Research Staff in Less Time

    9 July, 2015 Sandra Maddock, President & CEO, IMARC Research

    There has never been a more exciting time to be involved in clinical research. We’re seeing more advances in life-changing medical devices and pharmaceuticals than at any other time in history, creating a growing demand for qualified clinical research associates.

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  • 4 Reasons Why Document Review is Crucial to Compliance

    25 June, 2015 Cindy Fazzi Editor, MasterControl Insider

    When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.

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  • Why Do You Do What You Do?

    31 March, 2015 Jon Beckstrand CEO, MasterControl Inc.

    Have you ever asked yourself why you do what you do? When you find yourself buried in quality procedures and SOPs, or embroiled in a heated meeting over incomplete CAPA tasks, do you ever question the meaning of your work?

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  • My eQMS Consultant is Gone—Now What? 4 Post Go-Live Survival Tips

    30 July, 2015 Stephanie Jones, Senior Professional Services Consultant, MasterControl

    In my April 9, 2015 post, I offered eight tips for planning a seamless software go-live. This post picks up where that one left off to answer an important question many clients wrestle with after a successful go-live: What do you do when your software implementation consultant is no longer part of your day to day operations?

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  • What Quality Really Means: Three Key Principles

    4 August, 2015 Lane Hirning, Product Management Director, MasterControl Inc.

    A friend of mine recently asked me to review his PowerPoint presentation for an upcoming investor conference, which I was happy to do. The first thing that struck me was his choice of fonts—different types and different colors. Second was the slide templates creating an inconsistent layout. It seemed like a trivial thing to point out, but I had to ask him: What kind of a first impression are you going to make with this presentation?

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  • FDA Requests Public Input on Quality Metrics Guidance

    27 August, 2015 Oliver Wolf, Senior Product Manager, MasterControl

    In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) released the draft guidance “Request for Quality Metrics” and is now seeking public input by September 28, 2015 on a number of key points.

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  • Building Forms for Regulated Environments: Top 10 Best Practices

    8 September, 2015 Cindy Fazzi, Editor, MasterControl Insider

    Whether you’re applying for a job or a loan, or registering for a conference or membership in some organization, there’s one thing you must do—fill out a form. We can’t live without forms. In regulated environments, they are even more crucial because they can affect regulatory compliance.

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  • Multipurpose Tool vs. Best-of-Breed Platform: How to Tell the Difference

    15 September, 2015 Paul Sanderson, Solutions Consultants Group Lead

    When we invest in tools, we naturally want the most bang for our buck. Who hasn’t tried to use a screwdriver as a pry bar or a pair of pliers for loosening a bolt when a properly sized wrench would be more appropriate?

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  • Hacking GMPs: Deliberate Attacks or Accidental Workarounds?

    17 September, 2015 Vivian Bringslimark, President & Owner, HPIS Consulting, Inc.

    The subtitle tells it all. Most employees don’t come to work with the intention to cause harm, fail or make mistakes intentionally. Yet mistakes, errors, and failures happen. According to Sidney Dekker, author of The Field Guide to Understanding Human Error, “mismatches between written guidance and operational practice always exist”. I’s due to “the amount of increasingly tight constraints of procedures” (p.8). There have been some occasions where following a procedure could have caused a deviation if it weren’t for an astute technician who questioned the “GMP” rule. Talk about a GMP dilemma, “always follow the SOP” but don’t create a deviation either. Alas, we have a classic example of a white hat hacker.

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  • Secrets of Form Design: Forms Can Be Fantastic

    24 September, 2015 Nye Joell Hardy, Food Safety Technical and Regulatory Writer

    Okay, you’re ready. You have your policy. You have a great plan. You have the SOPs. Now all you need to do is implement it!

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