GxP Lifeline

 

Showing items tagged as Document Control

  • Top 5 Nutraceutical Trends: Going Green With Packaging

    3 October, 2019 by Sarah Beale, Staff Writer, MasterControl

    Plastic is the new GMO. It’s experiencing similar ostracization due to the large amounts of plastic produced each year that winds up in landfills and in the ocean. Moving away from a plastic dependency requires nutraceutical companies to be prepared with innovative ideas and a manufacturing process that is easily adaptable.

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  • Life Sciences Companies Can Achieve Greater ROI by Digitizing Their Data

    10 September, 2019 by Bryant Headley, Customer Success Executive-Governments, MasterControl

    Though we’re well into the 21st century, document control in the life science and health care sectors remains largely a paper-based system. Learn from a seasoned professional who worked for the U.S. Food and Drug Administration (FDA) and the U.S. Department of Veterans Affairs how going digital can significantly reduce risk while simultaneously providing you with both greater soft and hard ROI.

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  • Prelude to an FDA Warning Letter

    27 August, 2019 by David Jensen, Staff Writer, MasterControl

    Receiving an FDA warning letter usually sets off a chain reaction of required responses, follow-up tasks and additional correspondence that effectively keeps a regulated company from getting product out the door. This article discusses some of the common reasons life sciences companies receive warning letters and provides tips on how to avoid receiving one.

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  • How Digital Document Control Boosts Manufacturing Efficiency

    4 June, 2019 by David Jensen, Staff Writer, MasterControl

    Regulated companies are often reminded that if it isn’t documented, it didn’t happen. It’s also safe to say if it is documented, but the documents can’t be found, it didn’t happen. Efficient document control is at the core of quality management, compliance and getting products out the door.

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  • Enlist in the Paperless Revolution: Gain the Digital Advantage

    25 April, 2019 by Mike Rigert, Staff Writer, MasterControl

    Revolutions often take just the smallest act to become a widespread movement for change. J. Sterling Morton kicked off a worldwide forestation revolution in 1872, aka, Arbor Day. And digital transformation is currently revolutionizing the way life sciences and manufacturing companies do business. Declare “War on Paper” by joining the call to arms to go paperless.

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  • Apply ISO 9001:2015’s HLS for Improved Document Control and Compliance

    5 March, 2019 by Mike Rigert, Staff Writer, MasterControl

    ISO 9001:2015 is currently a key focus for transition for many life science and other regulated industry organizations. The high level structure (HLS) format within the standard has explicit requirements and when implemented with a robust quality management system (QMS), can help companies improve their document control processes and compliance levels.

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  • Using Sherlock Holmes to Pick a Consultant

    23 January, 2019 by Sarah Beale, Staff Writer, MasterControl

    When you’re faced with a daunting task, it can be tempting to bring in a consultant to deal with it. Depending on the circumstances, this can be a great idea or a disaster. Fortunately, there are a few lessons from the world’s only consulting detective that can help you make this decision.

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  • Costs of Paper: Hard vs. Soft ROI

    23 January, 2019 by Bryant Headley, Sr. Director of Regulatory Affairs and Executive Government Liaison, MasterControl

    Though we’re well into the 21st century, document control in the life science and health care sectors remains largely a paper-based system. Learn from a seasoned professional who worked for the U.S. Food and Drug Administration (FDA) and the U.S. Department of Veterans Affairs how going digital can significantly reduce risk while simultaneously provide you with both soft and hard ROI.

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  • What's Hiding in Your Labeling Artwork?

    23 October, 2018 by Dan Vuksanovich, Regional Sales Manager, Schlafender Hase

    Because there are potential but invisible risks inherent in labeling artwork documents of life science companies that can’t be detected through manual proofreading, it’s important to be thorough and to know the tricks to detect and prevent these snags from causing unnecessary delays in the manufacturing process.

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  • The #1 Gap in Manufacturing Software Today

    18 July, 2018 by Beth Pedersen, Staff Writer, MasterControl

    It’s 2018 and technology has pervaded every area of our lives. Yet a visit to almost any manufacturing floor reveals that paper is alive and well, even in forward-thinking companies with strong IT strategies and digital transformation initiatives in place. Why is it that the truly paperless factory floor remains so elusive?

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  • Top 5 Medical Device Industry Trends in 2018: Atypical Medical Device Technology Will Become More Typical

    28 June, 2018 by David Jensen, Staff Writer, MasterControl

    Technology companies outside of the health care sector continue to carve out a niche in the medical device industry. This trend makes the competition more flammable. Still, in many ways, disruptive technology developers may need to call upon their incumbent counterparts for assistance with navigating the regulatory pathway to compliance. This article discusses some of the regulatory stumbling blocks that could impact non-traditional medical device developers.

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  • What Biotech Startups Need to Do to Slay the Competition

    21 June, 2018 by Matthew M. Lowe, Executive Vice President of MasterControl

    Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

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  • Medtech Startups: How to Survive Cutthroat Competition

    19 June, 2018 by Matthew M. Lowe, Executive Vice President, MasterControl

    In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years. If you’re a startup, is it time to sit back and relax? Hardly.

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  • The Link Between Regulation, Quality Systems and Data Integrity, Part 2

    31 May, 2018 by Philippe Charbon, CEO of Apsalys, a European value-added Partner of MasterControl

    An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.

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  • FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 1

    22 May, 2018 by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

    Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The first part of a two-part series.

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  • How to Minimize Protocol Deviations

    1 May, 2018 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    Get off the list of the U.S. Food and Drug Administration's (FDA) most common site inspection finding — protocol deviations. Make sure your staff read and understand protocols, how they work and what types of deviations inspectors are looking for.

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  • UK's MHRA Issues Final Guidance on GxP Data Integrity

    19 April, 2018 by Mark Schwartz, Director, Hyman, Phelps & McNamara

    Glean some insights from the U.K. 's Medicines and Healthcare Products Regulatory Agency (MHRA) recently published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).

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  • Poll Suggests Automation Could Solve 85% of Your Document Control Issues

    20 March, 2018 by Mike Rigert, Staff Writer, MasterControl

    The sophistication and value-added benefits of automated, integrated document control management tools available to manufacturers in the life sciences has come a long way since software solutions were introduced in the 1980s on 5 1/4-inch floppy disks.

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  • February Tip: Managing Updates to Regulatory Documentation

    22 February, 2018 Tamara Burch-Williams, Professional Services Implementation Manager, MasterControl

    Tip: When the change occurs, review the current regulatory submission(s) and note where updates are needed. Even better, create a working or dynamic version of an updated submission.

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