GxP Lifeline
  • 2020-bl-thumb-5-myths-about-cloud-security

    Webinar Dispels Myths About Cloud Security

    More companies in all industries are migrating to a cloud environment to benefit from the advanced computing power, abundant data storage, and ability to perform complex functions. The cloud provides significant value; however, security has often been a source of concern. This article dispels the five most common myths about cloud security.

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  • 2020-bl-thumb-coda-corp-fda-and-data-integrity

    "In a Data-Driven Ecosystem, Don't Let Data Integrity Be Your Achilles' Heel"

    Data has massive potential to revolutionize the life sciences for patients, regulators and for manufacturers. Yet at the same time, data integrity remains one of regulatory bodies’ biggest concerns. Learn what you can do to improve your company’s data integrity for regulatory inspections.

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  • 2020-bl-thumb-3-personalized-medicine-trends-for-2020

    3 Personalized Medicine Trends for 2020

    The idea behind personalized medicine has always been the goal for health care professionals, but it’s becoming truly achievable with recent advances in technology. For pharmaceutical and medical device companies in the market, here are three trends to help you through 2020.

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  • 2020-bl-thumb-pharma-trends-brief

    Top 5 Pharmaceutical Manufacturing Trends in 2020

    The pharma industry has been gathering no moss going into 2020. New pharmaceutical manufacturing trends have been rapidly emerging, accompanied by regulatory initiatives to help mainstream the innovations. A new trend brief from MasterControl discusses how the new trends will impact the pharma industry.

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  • 2020-bl-thumb-robotic-process-automation

    Life Sciences Look to Increase Productivity Through Robotic Automation

    With all the new digital technologies impacting the life sciences, don’t forget about robotic process automation (RPA). The potential of RPA to automate repetitive, data-intensive processes can increase efficiencies and quality while freeing up your staff for more meaningful functions and assignments.

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  • 2020-bl-thumb-the-love-affair-quality-manufacturing

    When Quality Met Manufacturing

    It’s February, so stores are flooded with Valentine’s Day candy, flowers and greeting cards. None of these are for the quality-manufacturing relationship, but it still deserves some attention. If your quality and manufacturing departments have enough drama to give a rom-com a run for its money, it’s time to take the first step to bringing them together.

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  • 2020-bl-thumb-epibone-video-case-study

    EpiBone Embodies Paperless Efficiencies in Personalized Medicine

    In a new case study video, EpiBone, a Brooklyn-based regenerative medicine company developing living grafts for skeletal reconstruction, explains how it is leveraging MasterControl's QMS and manufacturing software to reduce errors and increase efficiency in the management of its quality processes and production records.

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  • 2020-nl-bl-thumb-shifting-data-centric-quality

    Quality’s Unstructured Data Dilemma: 3 Reasons to Overcome Document Dependency

    Companies whose quality management practices are document dependent are neglecting the insights trapped in their quality data. Learn about the promise and peril of unstructured data and how connectivity can unlock your quality function’s potential.

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  • 2020-bl-thumb-cmos-and-accenture-study

    Disruptive Outsourcing Means Life Sciences Are Relying on CMOs More Than Ever

    Life sciences manufacturers’ reliance on outsourcing is on an upward trajectory. However, recent disruptions to how and why companies turn to contract manufacturing organizations (CMOs) and related contract services are changing the playing field. To maintain quality and control of products in this more dynamic outsourcing ecosystem, companies should seek greater collaboration.

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  • 2020-bl-thumb-importance-of-intended-purpose

    The Importance of Intended Purpose and State of the Art in Implementing EU’s IVDR

    The European Union’s In Vitro Device Regulation (IVDR) is replacing the In Vitro Device Directive (IVDD) on May 20, 2022, and there’s not a moment to spare in preparing for the new regulation. An in vitro diagnostic (IVD) expert with QServe lays out the most important requirements of IVDR that IVD manufacturers will need to begin planning for to recertify their devices.

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  • 2020-nl-thumb-augmented-intelligence

    Augmented Intelligence Helps Clarify Human/AI Roles in the Workplace

    For decades, the science fiction world has often included some version of artificial intelligence (AI). While audiences were watching AI entities and robots come alive on the big screen, technology scientists were busily researching and developing the real thing. This article discusses the concept of augmented intelligence and how it underscores the importance of human creativity and innovation in the context of advanced technology and artificial intelligence.

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  • 2020-bl-thumb-adios-device-excise-tax

    Christmas Comes Early to Medtech: U.S. Repeals Device Excise Tax

    With the release of the ninth and final Star Wars film in the so-called Skywalker saga, December 2019 was a big month for fans. It was even a bigger month in the medtech galaxy, where the U.S. Congress’ permanent repeal of the 2.3% device excise tax extends a prime opportunity to device makers to reinvest the savings in cost-competitive measures.

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  • 2020-bl-thumb-data-driven-quality-new-years-resolutions

    3 New Year’s Resolutions for Your Company

    The new year is the typical time when we set resolutions to improve ourselves. Since companies are in need of improvement too, make a resolution to digitize your business. If you’re not sure how to start, we’ve got some ideas.

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  • 2019-bl-thumb-to-pre-sub-or-not-to-pre-sub

    To Pre-Sub or Not to Pre-Sub? Weighing the Value of the FDA’s Pre-Submission Program

    The U.S. Food and Drug Administration’s Pre-Submission program was created to with the intent of lowering medical device companies’ submission times. Gain some valuable insights about how the program can help you get clearance for your device and increase speed to market.

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  • 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-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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