• 2021-bl-fda-483-observation_132x132

    Top Reasons for Med Device Form 483s and Warnings

    Maintaining compliance in medical device manufacturing is colossal and complex. Any number of things can slip through the cracks and fall into the lap of a regulatory inspector. MasterControl’s industry brief “Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments” helps companies identify and mitigate issues before they lead to extra work and costly delays.

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  • 2021-bl-disaster-recovery_132x132

    Disaster Recovery and Validation Fears Have a Remedy: The Cloud

    Natural and man-made disasters aren’t just terrifying – they can signal the death of your business if they lead to data loss, prolonged system outages, or downtime. Learn why cloud technologies take the panic out of disaster recovery and validation.

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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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  • 2021-bl-rajesh-talpade-_132x132

    The Future of Responsible AI in Life Sciences

    In life sciences, we are rapidly approaching a time when the use of artificial intelligence and machine learning (AI/ML) will be an industry norm.

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  • 2021-bl-quality-assurance-quality-control_132x132

    Quality Assurance and Quality Control: What's the Difference When It Comes to Managing Quality?

    Quality assurance and quality control aren’t identical or interchangeable. Comparing the two functions to television’s most enduring police crime drama might help you explain their differences to your peers.

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  • 2021-bl-enterey-paperless-to-digital_132x132

    Ask Aimy: The 4 Steps to Going Digital

    As companies learned during the pandemic, going digital is easier said than done. That’s why life sciences consulting firm Enterey uses a four-step process to help their clients transform their businesses. To walk us through it, we chatted with Manager Aimy Rehm about how to practically apply the steps and some potential scenarios companies may face.

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  • 2021-bl-personalized-medicine2_132x132

    Harnessing Data to Drive Improvements in Precision Medicine

    New technologies are enabling innovative advances in precision medicine. They are also generating vast amounts of data – across clinical studies, laboratories, patients, products, and more. As more enormous, disparate data sets are created, organizations need to be able to track, store, and analyze the information quickly and accurately. To fulfill the promise of precision medicine, organizations must harness all that data through greater connectivity and interoperability, increased visibility, and more data-driven insights.

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  • 2021-bl-implementing-a-qms_132x132

    10 Key Steps for Implementing a QMS

    Your company needs to an integrated, automated quality management system (QMS) to help you get your products to market faster and more efficiently. Where do you start? Consider these 10 steps to help you audit your current system and processes, get stakeholders onboard, and implement a QMS that will signifcantly improve your company's quality processes.

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  • 2021-bl-career-in-quality-management-pt-2_132x132

    Pursuing a Career in Quality Q&A — Part 2

    The quality management career has its ups and downs. We’ve already explored how to get into quality — now Quality Engineer Natalie Weber shares the good, the bad, and the hilarious parts of the job.

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  • 2021-bl-2021-mx-webinar-recap_132x132

    How Digitization Enables Safe, Connected Operations in Manufacturing

    As manufacturers continue to work through COVID-19 challenges and beyond, they must focus on ensuring workforce safety and productivity on the shop floor while enabling a connected, productive workforce that may be partly remote – and need to do so in ways that keep employees safe. A recent webinar with MasterControl SVP of Strategic Growth Brian Curran and Product Manager Katie Farley discussed some production challenges revealed by COVID-19, and reasons to digitize.

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  • 2021-bl-career-in-quality-management_132x132

    Pursuing a Career in Quality Q&A — Part 1

    The quality management career path isn’t as straightforward as getting a bachelor’s in quality management, which can be problematic if you’re considering a career in quality. That’s why we sat down with a quality expert to find out how to start a career in quality and what that looks like on a day-to-day basis.

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  • 2021-bl-coda-corp-quality-personnel_132x132

    Think Systems: Cause Quality

    With the right system, you can achieve and sustain a high level of quality. This includes having the ability to capture objective, up-to-date information so you can make data-driven decisions.

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  • 2020-bl-quality-excellence-03_132x132

    Solving Quality Problems: Go Beyond Root Cause to ‘Real’ Cause

    Extrapolating the root cause of a quality problem isn’t the same as determining the problem’s real cause. Learn how to discern real causes and avoid the cycle of recurring root cause investigations.

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  • 2020-bl-manufacturing-excellence-03_132x132

    Maintaining Quality in the Fast-Paced Contract Manufacturing Industry

    All eyes are on contract manufacturers to help make COVID-19 vaccinations available throughout the globe. Increased scrutiny of the industry has brought an issue to the forefront: maintaining product quality while working at a rapid pace. With a modern manufacturing solution, it’s possible to prioritize both.

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  • 2021-bl-compliance-checklist_132x132

    Q&A: A Risk-Based Approach to Compliant Audit Trails

    More regulated companies have transitioned to maintaining records and submitting information electronically. This involves tight data and records management and audit trails. In this article, Seyed Khorashahi, executive vice president of medical devices and CTO at Regulatory Compliance Associates (RCA) Inc., shares valuable insight on the anatomy of an audit trail and advises companies on how to comply with this critical component of 21 CFR Part 11.

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  • artificial-intelligence-132

    AI: Regulatory Framework for SaMD – Part Two

    The U.S. Food and Drug Administration (FDA) has proposed a regulatory framework around Artificial Intelligence/Machine Learning (AI/ML) for software as a medical device (SaMD). In the second part of a two-part series, past and current regulations are explored and explained.

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  • 2021-bl-mx-trend-brief_132x132

    4 Considerations for Manufacturers When Applying Digitization

    The movement toward digitization in manufacturing isn’t new, but the events of 2020 forced many organizations to adopt digital solutions quicker than previously planned. The digital changes that companies made over the past year are likely to remain after the crisis. As manufacturers look for ways to leverage technology to improve operations, they should consider at the following four ways to apply digitization.

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  • 2020-bl-matt-brawner-qa_132x132

    Risk Management: A Primer for Lean Quality Assurance

    Be proactive about managing risk. If you aren’t, you will find yourself managing a crisis instead. Learn more about the benefits of risk management and how it’s done.

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  • 2021-bl-cannon-qa-expenses_132x132

    Medtech Startups: Four Approaches to a QMS

    Early stage startups in the medical device/Medtech/in vitro diagnostic (IVD) world often struggle with when and how to implement a quality management system (QMS) into their operations.

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  • 2021-bl-mpr-ai-regulations_132x132

    AI: Regulatory Framework for SaMD – Part One

    As Artificial Intelligence/Machine Learning (AI/ML) gain momentum, particularly in software as medical device (SaMD), a regulatory framework is being put in place by the U.S. Food and Drug Administration (FDA). In the first part of a two-part series, the benefits of AI/ML are discussed along with the numerous considerations that need to be taken into account by regulatory bodies.

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