• Still Using Paper for Audits? Here’s Why You Need to Automate

    27 October, 2015 Steve Harrison, Product Manager, MasterControl

    A recent quality management system benchmark survey showed manual processes are still predominant over automated systems.[1] The results of the survey were compiled from over 100,000 professionals worldwide and the majority of the participants work in quality or regulatory positions across pharmaceutical, medical device and biotech industries.

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  • 6 Traits You Should Develop to Become an Exceptional Quality Pro

    22 October, 2015 Cindy Fazzi, Editor, MasterControl Insider

    In a regulated company, quality professionals may be revered or dreaded or downright misunderstood. But there’s no denying their important role. As quality guru Joseph Juran said, all improvement happens project by project and in no other way. To paraphrase Juran, I would say a high-quality product or service happens step by step and process by process. Guess who’s responsible for making sure every step and every process is working effectively? You got that right—quality pros.

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  • Trust is Not Just Nice, It’s the Key to Your Success

    19 October, 2015 Cindy Fazzi, Staff Writer

    Whether you’re a quality professional responsible for your system implementation or a CEO getting ready to launch a medical device startup, Stephen M.R. Covey believes there’s one thing you need to succeed—trust. “Trust is an economic driver, not merely a social virtue,” he said in his keynote address at the 2015 Masters Summit.

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  • Quality Audit: The Direct Route to Continuous Improvement

    6 October, 2015 Beth Pedersen, Marketing Communications Specialist, MasterControl

    If your organization is GxP-regulated or ISO-certified, you are no stranger to the burdens of audit. The regulations and standards that govern your operations change often, and yet you must somehow manage to understand and comply with them – and be able to clearly demonstrate your compliance – at all times.

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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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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