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GxP Lifeline
  • 2022-bl-software-validation_132x132

    6 Steps to Simplify Software Validation

    The FDA requires companies to validate software used in regulatory environments. But the processes involved in validation are usually a drain on your time and resources. By following six fundamental steps, you can adopt and validate software systems with greater ease.

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  • 2021-bl-med-device-managing-risk_132x132

    5 Medical Device Best Practices for Managing Risk to Users, Patients, and the Environment

    Medical device companies can take a risk-based approach, which simplifies regulatory compliance while alleviating concerns about speed-to-market and new device clearance overhead costs to maintain compliance.

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  • 2021-bl-standards-harmonization-and-eu-mdr_132x132

    5 Tips to Manage the EU MDR Harmonized Standards

    With the roll out of the EU’s Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR), an increasing number of harmonized standards are out of date. This post addresses the current status of harmonized standards under MDR/IVDR and provides tips for dealing with the challenges of meeting compliance with the new regulations.

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  • 2021-bl-qarad-eifu_132x132

    What do Notified Bodies expect of your eIFU solution and its implementation?

    It is often crucial for safety that users have access to the correct instructions for use (IFU) when they need it. Therefore, it is logical that eIFU solutions are subject to strict requirements. Consequently, notified bodies (NB) will verify how a manufacturer has designed and implemented their eIFU solution in agreement with the requirements.

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  • 2020-bl-manufacturing-excellence-06_132x132

    GxP Training Redefined?

    To meet GxP training requirements, it’s important to understand the basics: what GxP means, how it relates to regulatory compliance, and how organizational change management can help you ensure your team receives adequate and consistent training.

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  • 2021-bl-transitioning-ivdr_132x132

    Challenges with Transitioning to the EU In Vitro Diagnostic Devices Regulation

    The deadline for the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) is about a year away, and if you haven’t started preparing, now is the time. Understand the challenges you might face during the process and what you can do to address them.

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  • 2019-bl-thumb-prepare-for-the-future-of-quality-now

    5 Ways to Prepare for the Future of Quality Now

    The future of quality is closer than you might think, and the time to prepare is now. During the 2019 Masters Summit, MasterControl Partner KPMG presented a session on the future of quality and how it can help the life sciences industries now.

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  • 2019-bl-thumb-brandwood-transition-from-mdd-to-mdr

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

    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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  • 2019-bl-thumb-how-the-tga-regulates-drugs-and-devices

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

    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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  • 2019-bl-build-an-effective-global-regulatory-strategy-page-image

    Building an Effective Global Regulatory Strategy for Medical Devices

    As new technologies evolve, the device requirements for medical device companies in various global markets has become more complex and nuanced. To be successful in key markets around the world, device makers need to study these regulatory environments and develop a strategy to more seamlessly and efficiently acquire regulatory approvals.

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  • 2018-bl-thumb-shifting-reimbursement-landscape-australia

    Getting Paid: A Shifting Medical Device Reimbursement Landscape in Australia

    Australia is increasingly an attractive market for medical device manufacturers. But medtech companies need to know the complexities of the country’s blended public and private hospital systems to avoid confusion and fully profit from its device reimbursement opportunities.

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  • laboratory-bio-data-analyst-132

    Keeping Up With Regulatory Changes for Medical Devices

    Don’t let the cash flow slow when new regulatory guidance for medical device manufacturers is handed down by the FDA and other agencies in FY2018. Rather, follow these simple steps that will allow you to get your device to market faster to help your company maximize profit and minimize delays.

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  • 2018-bl-thumb-top-5-nutraceuticals-functional-food

    Top 5 Nutraceutical Trends in 2018 – Functional Foods

    The dietary supplement and functional foods markets overlap to a certain extent. Rather than trying to resist this, nutraceutical companies can get the best of both worlds by expanding their offerings to include functional snacks and beverages.

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  • MasterControl Logo

    Regulatory Manager Tip: Making Your Voice Heard at the FDA

    As a life science manufacturer, how can I minimize risk and hiccups before seeking U.S. Food and Drug Administration approval for my product? Learn how to make your voice heard at the FDA in this month’s Regulatory Manager Tip.

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  • 2020-bl-connectivity-02_132x132

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

    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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  • 2018-bl-thumb-fdas-top-10-drug-gmp-inspection-citations-2017

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

    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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  • 2018-bl-thumb-top-med-device-trends-asia-pacific

    Top Medical Device Trends in Asia-Pacific and Around the World

    The speed at which the medical device industry is changing and evolving is perhaps unrivaled in the life sciences industry. Medical device manufacturers are experiencing disruption from small companies and startups entering the market1, tech giants like Amazon are investigating and investing in medical device expertise and cybersecurity concerns are on the rise.

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  • 2018-bl-thumb-proving-effectiveness-mock-audits

    Proving the Effectiveness of Mock FDA Audits

    A mock U.S. Food and Drug Administration (FDA) audit can be conducted by an internal team of employees qualified by experience in regulatory compliance or by an external team with previous FDA work experience. Incorporating routine mock FDA audits can help your organization prepare for a FDA audit as well as reduce the number of audit observations and repeat observations received from regulatory authorities.

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  • 2018-bl-thumb-british-mhra

    UK's MHRA Issues Final Guidance on GxP Data Integrity

    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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  • 2020-bl-manufacturing-excellence-06_132x132

    Top 5 Pharmaceutical Trends to Keep on the Radar in 2018

    Get up to speed on key takeaways from what are expected to be some of the most tranformational trends to affect the pharmaceutical industry in 2018. And for further analysis of some of the top trends in pharmaceuticals this year, check out the associated white paper.

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