• 2019-bl-thumb-3-critical-keys-integrated-management

    3 Keys to Implement an Integrated Management System With ISO 9001

    Life sciences companies that implement an integrated management system (IMS) can provide both improved compliance with ISO 9001:2015 while also better aligning your organization’s quality system and business model. Learn how to harmonize your systems.

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  • 2019-bl-thumb-harmonized-standards

    The Standards Harmonization Process and 5 Tips to Manage It With EU MDR

    There’s been considerable disquiet over the lack of available harmonized standards to support the European Union’s Medical Device Regulation (MDR). Learn about European harmonization standards processes and how medical device manufacturers can best manage the current state of regulatory uncertainty.

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  • 2019-bl-thumb-purpose-bulit-manufacturing-systems

    Purpose-Built Manufacturing Systems: Once a Virtue, Now a Vice

    As technology and the marketplace undergo drastic change, it seems the ROI of enterprise manufacturing software systems has reached a tipping point. But with the help of new additive technologies and small automation efforts, core systems will continue to play a significant – albeit evolving – role in modern manufacturing.

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  • 2019-nl-bl-thumb-elf-on-shelf

    Santa’s Little Auditor

    It’s the time of year for parents to pull out the Elf on the Shelf and regale their children with stories of how their behavior gets reported back to Santa. Making sure those reports are accurate depends on whether the elf is using paper or digital solutions.

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  • 2019-bl-thumb-the-surge-of-manufacturing-data-integrity-violations

    Surge of Data Integrity Violations Irritating the FDA

    Regulatory agencies cannot feasibly review every process and every bit of data at every regulated company. This is why they rely on manufacturers to provide complete and accurate information in their submissions. Still, data integrity violations remain the most common reason why medical product companies receive Form 483s and warning letters. For this reason, life sciences companies seeking regulatory approval for products should expect to ramp up their data management efforts.

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  • 2019-bl-thumb-proposed-ratings-system-measure-drugmakers

    The FDA Mulls Proposed Ratings to Measure Drugmakers’ Manufacturing Quality

    A recent U.S. Food and Drug Administration (FDA) report indicates one of the reasons for drug shortages in the U.S. is the absence of incentives for manufacturers’ facilities to go beyond minimal quality compliance. A proposed voluntary FDA ratings system based on objective criteria could potentially benefit and reward drugmakers for their facilities’ heightened quality manufacturing maturity.

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  • 2019-bl-thumb-innovation-and-compliance-cochlear

    Innovation and Compliance Harmonize Perfectly at Cochlear

    Cochlear’s cochlear implants are more than just groundbreaking medical devices — they’re a life-redefining means through which people with hearing loss to connect with the world. Learn how the company is bringing innovative products to more people in need by accelerating quality and compliance processes with robust digital solutions.

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  • 2019-bl-thumb-the-road-to-digital-manufacturing

    Digital Supply Networks and Smart Factories: The Future of Manufacturing

    The further we go into the 21st century the more it becomes apparent that the future of manufacturing will be digital. Find out how digital supply networks and smart factories will form the backbone of the digital transformation and what role quality and an automated quality management system (QMS) will play as manufacturing enters the Fourth Industrial Revolution.

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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-survive-holiday-cooking-with-recipe-management

    Survive Holiday Cooking With Recipe Management

    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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  • 2019-bl-thumb-mdsap-world-of-opportunity-med-devices

    Why MDSAP Opens a World of Opportunity for Med Devices

    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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  • 2019-bl-thumb-fda-unveils-draft-guidance-on-asca

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

    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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  • 2019-bl-thumb-a-charlie-brown-audit-1

    It’s A Charlie Brown Audit

    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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  • 2019-bl-thumb-world-quality-day

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

    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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  • 2019-nl-bl-thumb-assessment-elevens

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

    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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  • 2019-bl-thumb-validation-conference-takeaways

    Top 4 Takeaways From Validation Week

    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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  • 2019-bl-thumb-top-trends-new-improved-validation

    Top Trends for New and Improved Validation

    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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  • 219-bl-thumb-rip-paper-processes

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

    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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  • 2019-bl-thumb-top-5-reasons-to-join-the-war-on-paper

    Top 5 Reasons to Join the War on Paper

    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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  • 2019-bl-thumb-mdm-minneapolis-takeaways

    Productive Connections: Integrating Quality and Production

    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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