GxP Lifeline

 

  • Survive Holiday Cooking With Recipe Management

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

    If you’re stressed about holiday meal preparation, get some help from digitizing your system. Trade out the flour-crusted recipe notecards for a recipe management system that brings precision to your cooking. This year, it’s the only way to face your in-laws with confidence.

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  • Why MDSAP Opens a World of Opportunity for Med Devices

    26 November, 2019 by David Jensen, Staff Writer, MasterControl

    Global regulatory agencies are rallying to help drive the momentum for medical device innovation. The International Medical Device Regulators Forum (IMDRF) recently implemented a regulatory consortium called the Medical Device Single Audit Program (MDSAP). The program is designed to grant regulatory approval of medical devices in several global regions through a single audit. In this article, Luis Jimenez, vice president of business development at Brandwood CKC, discusses why this program is highly beneficial for medical device manufacturers.

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  • The FDA Unveils Draft Guidance on ASCA for Device Conformity Assessment Testing

    21 November, 2019 by Mike Rigert, Staff Writer, MasterControl

    The U.S. Food and Drug Administration (FDA) recently received draft guidance on its proposed pilot program, the Accreditation Scheme for Conformity Assessment (ASCA), for medical device premarket reviews. The intent of the pilot is to realize greater efficiencies and confidence in the testing and reviews process for all involved parties. Find out if ASCA might be viable for your organization.

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  • It’s A Charlie Brown Audit

    19 November, 2019 by David Jensen, Staff Writer, MasterControl

    Over the years, Charlie Brown and the Peanuts gang have regaled us with TV specials featuring their own brand of holiday celebrations. One show that never made it to the airwaves was the gang’s experience operating a medical device manufacturing plant that was having an audit. This article describes how that event played out.

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  • World Quality Day 2019: Celebrating the Past, Present and Future of Quality

    14 November, 2019 by Beth Pedersen, Staff Writer, MasterControl

    Have you ever thought about what quality means to you? It may mean something different to everyone, but its power to change lives for the better unites people around the world. On World Quality Day, we celebrate this uniquely human concept and the impactful work of quality professionals everywhere by taking a moment to reflect on the past, present and future of quality.

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  • An Assessment of the ‘Elevens’: EU’s Annex 11 and FDA 21 CFR Part 11

    13 November, 2019 by Mike Rigert, Staff Writer, MasterControl

    The European Union’s Annex 11 and the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 good manufacturing practice (GMP) guidances cover much of the same regulatory ground but also have differences. Find out how both regulatory documents affect life sciences manufacturers.

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  • Top 4 Takeaways From Validation Week

    12 November, 2019 by Sarah Beale, Staff Writer, MasterControl

    In October, the 25th Annual Validation Week was held in Las Vegas, Nevada. The presenters included current and former employees of the U.S. Food and Drug Administration (FDA), and validation experts from the life sciences. This article explores the prevalent themes from the conference and how they will change validation.

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  • Top Trends for New and Improved Validation

    7 November, 2019 by Sarah Beale, Staff Writer, MasterControl

    Technology’s getting more advanced and our validation practices are finally starting to catch up. During the 2019 Masters Summit, Validation Product Manager Erin Wright gave us a glimpse at what’s in the future. Read about the next big trends in validation, including the U.S. Food and Drug Administration’s (FDA) stance.

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  • Manufacturers See Sizable Gains in the Leap From Paper to Digital Data

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

    The digital transformation and the ensuing War on Paper are changing the way life sciences manufacturers view speedy yet compliant production and the way they calculate ROI. Increasingly, companies are foregoing manual data systems in favor of a more efficient and cost-effective digital solution.

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  • Top 5 Reasons to Join the War on Paper

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

    The War on Paper is being waged against paper-based systems and is won by digitizing. Recently, MasterControl partnered up with DocuSign on a webinar discussing the benefits of going digital. Read some of the highlights or watch the webinar recording if you missed it.

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  • Productive Connections: Integrating Quality and Production

    29 October, 2019 by David Butcher, Staff Writer, MasterControl

    In a recent presentation at MD&M Minneapolis, Terrance Holbrook, director of product at MasterControl, and Robert DePalma, VP of regulatory affairs at Pyrexar Medical, explained how manufacturers that digitally connect their production record system with other data sources will quickly stand apart from competitors.

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  • Q&A: Device Manufacturers’ FAQs on the EU’s Medical Device Regulation (MDR)

    24 October, 2019 by Mike Rigert, Staff Writer, MasterControl

    Medical device manufacturers globally are grappling to recertify their devices against the European Union’s new Medical Device Regulation (MDR), which takes affect May 26, 2020. To help manufacturers make sense of the MDR, a Q&A was conducted with two medtech subject matter experts who tackle some of the most commonly asked questions about the MDR and how to approach it.

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  • Art Intersects With Inspiring Science Applications at the 2019 Masters Summit

    22 October, 2019 by James Jardine, Staff Writer, MasterControl

    Science and art may seem to have few commonalities, but creative achievements like origami models and musical compositions are closely linked with beneficial scientific applications, according to the keynote addresses at the 2019 Masters Summit. Learn about the insights that origami innovator Dr. Robert Lang and independent filmmaker Irene Taylor Brodsky have discovered in the space where art and technology intersect.

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  • Tips on How the TGA Regulates Drugs, Devices and Combination Products

    17 October, 2019 by Vergel Manalo, Team Lead – Medicines and Senior Consultant, Brandwood CKC

    Global regulatory requirements are seemingly in a state of constant flux. Thus, it can be confusing for life sciences companies to grasp the exact nature of each region’s regulatory agency policies. This article breaks down some of the regulatory basics and more nuanced portions of Australia’s Therapeutic Goods Administration (TGA).

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  • Different Year, Same Results: QA the No. 1 FDA Drug GMP Inspection Lapse for FY2019

    15 October, 2019 by Mike Rigert, Staff Writer, MasterControl

    The latest statistics from U.S. Food and Drug Administration drug GMP inspection citations for FY2019 are making the headlines, and the most common cited reason for manufacturer receiving a warning letter is a familiar one. This article looks at how technology and the latest tools available to pharma manufacturers can significantly increase quality and compliance levels and reduce the likelihood of regulatory warnings.

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  • Top 5 Takeaways From IVT’s Data Integrity Validation Conference

    10 October, 2019 by David Jensen, Staff Writer, MasterControl

    The Institute of Validation Technology (IVT) recently hosted its fifth annual Data Integrity Validation conference (Aug. 14-15) in Waltham, Massachusetts. Subject matter experts from a variety of life sciences industries discussed critical aspects of data integrity and why it remains one of the most common inspection findings. This article highlights the valuable insights attendees gained about data management technologies and best practices.

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  • How Cloud Migration Has Become More Seamless for Regulated Companies

    8 October, 2019 by David Jensen, Staff Writer, Master Control

    Cloud technology has reached a level of maturity where many regulated companies are discovering that operating in the cloud is more cost effective and a competitive advantage. A new white paper discusses the benefits of moving to the cloud and how companies can make the migration process smoother and faster.

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  • 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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  • How Digitization Can Help Life Sciences Manufacturers Amplify Lean Principles

    1 October, 2019 by Dave Edwards, Executive Vice President, MasterControl

    Life sciences manufacturers are grappling for every advantage they can get in saturated, highly competitive markets. The implementation of lean programs is one way to achieve greater efficiencies. But in order to fully realize the benefits of lean, manufacturers need to replace manual paper-based data systems with a digital production records solution.

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  • Shop Floor Perspective: How Eliminating Paper Elevates the People at Wellington Foods

    26 September, 2019 by Beth Pedersen, Staff Writer, MasterControl

    As the manufacturing floor becomes more digitized and automated, a curious thing is happening. Instead of replacing human workers, advanced tech is highlighting the importance of people as decision-makers and innovators. The lesson that many companies are now learning firsthand is that if digital transformation is to fully deliver on its potential, it must support and adapt to human processes and preferences, not the other way around.

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