• 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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  • 2021-bl-analytics-trends-brief_132x132

    May the Data Be With You

    Using the Force to make decisions in Star Wars works well. Tragically, since most of us don’t have that ability in the real world, we’d probably be better served if we listened to C-3PO more. While we’re short on protocol droids, we do have the tools to let you make decisions using advanced analytics and artificial intelligence (AI). And the odds of those paying off are considerably better than navigating an asteroid field.

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  • 2021-bl-ipm-compliance-crisis_132x132

    How to Avoid—but Prepare for—Compliance Crises

    If you prepare for and manage compliance crises with disciplined leadership and formal processes, you can minimize disruption and damage. In fact, your processes, communication, and adaptability can get stronger from the experience.

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  • 2021-bl-quality-inspiration_132x132

    Quality Inspiration: 5 Quality Quotes for Industry Professionals to Consider

    For professionals in the business of quality, inspiration can be found in all sorts of ways, from studying other industries to browsing the patent office or even taking a different route to work. A simple but often motivating approach is to look to words of wisdom from experts in their fields. Here are five insightful quotations, from a variety of fields, that carry quite a bit of truth for quality professionals.

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  • 2021-bl-fda-cosmetic-act_132x132

    Life Before Consumer Protection and the Food, Drug, and Cosmetic Act

    Before the Food, Drug, and Cosmetic Act of 1938, shopping could be hazardous to your health. The market was flooded with deceptive and dangerous products. The confidence we have today in food, drugs, medical devices, and cosmetics is largely due to the FD&C Act and the amendments that followed.

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  • 2021-bl-medical-device-dhf_132x132

    Overview of the Medical Device Design History File, Technical File, and Design Dossier

    Medical device manufacturers must adhere to strict regulatory requirements, and the U.S. Food and Drug Administration’s 21 CFR Part 820 is a crucial set of regulatory guidelines meant to ensure the medical devices are high quality, safe, and effective. As part of these regulatory requirements, manufacturers must establish and maintain a medical device design history file (DHF) for each type of device. The following is an overview of the FDA’s design control and DHF expectations, as well as the role of the technical file/design dossier in European regulatory requirements.

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  • sara-bresee-thumb-gradient_132x132

    Insights Into APAC and Modern Manufacturing

    At MasterControl, we are broadening our gaze to the Asia-Pacific (APAC) region. Managing Director of APAC, Sara Bresee, weighs in on why modern manufacturing solutions are critical to APAC and around the globe. A digital system is what’s needed to be adaptable, meet regulatory requirements, and deliver the high level of quality your customers deserve.

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  • 2021-bl-embed-risk-based-thinking_132x132

    Embedding Risk-Based Thinking Into Quality Efforts

    Many of the challenges inherent in developing regulated products fall into the realm of risk that manufacturers need to examine and mitigate prior to going to market. Risk management guidelines are spelled out in international regulations and standards, but true risk management goes deeper and is applied throughout the product’s life cycle.

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  • 2021-bl-brandwood_132x132

    Transition Plan: From Custom Device to Patient-matched

    As of the February 25, 2021, the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 relating to the regulation of personalized medical devices was enacted. Understand the most notable changes.

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  • 2021-bl-unlocking-your-data-potential_132x132

    3 Data Access Enhancements That Expedite Drug Development and Approvals

    Regulators began increasing focus on data accuracy long before the pandemic, but it’s a trend that’s only continuing to gain more momentum. Discover how data connectivity improvements are helping pharma companies align with regulatory dynamics and get drug products to market faster.

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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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  • 2020-bl-connectivity-02_132x132

    A Q&A: the Trials and Triumphs of Validation

    Sequence Senior Consultant Peter McGrath weighs in on the struggles of traditional computer system validation (CSV), and how they can be solved with a risk-based approach. Months of time are spent on traditional CSV to the process, which produces piles of documentation. It doesn't have to be that way.

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  • 2021-bl-infrastructure-accessibility_132x132

    3 Practical Ways to Improve Infrastructure Agility in Pharma

    If nothing else, the COVID-19 pandemic proved to pharmaceutical companies that digitally integrated processes are the key to surviving a crisis. If your organization has difficulty connecting people, processes, and systems, there are three pragmatic measures you can take to bolster your existing infrastructure, help ensure secure connections, and enhance collaborative work.

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  • 2021-bl-personalized-medicine_132x132

    Harnessing Digital Transformation to Drive Innovation in Personalized Medicine

    In 2020, the COVID-19 pandemic brought to light the importance and acceleration of digitization. As precision medicine organizations continue reviewing and adjusting processes beyond the COVID-19 pandemic, there are some practical applications to consider in their efforts to embrace a modern approach to technology.

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  • 2021-bl-cmo-trend-brief_132x132

    CMOs and the Speed of Personalized Medicine

    In the growing field of personalized medicine, there are significant opportunities for contract manufacturers, and the challenge to keep up with demand can be met by adopting the right technology.

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  • 2021-bl-remote-audits_132x132

    Conducting Remote GxP Audits: Three Keys to Success

    The COVID-19 pandemic created unprecedented challenges for quality and compliance professionals in the pharmaceutical, biotech, and medical device industries. Staying on course toward product approval and audit schedules is dependent on maintaining a robust compliance roadmap, which includes sponsoring GxP audits.

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  • 2021-bl-weaver-logo_132x132

    Weaver and Company: Digitization Streamlined Quality and Production

    Since its founding in 1978, medical device manufacturer Weaver and Company has grown, regulations relevant to its products have evolved, and paper-based processes posed greater risk. Recognizing that managing paper quality and production documents was no longer practical, the Colorado-based company has taken steps to modernize with MasterControl's digital quality management and manufacturing solutions.

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  • 2021-bl-what-possible-life-sciences_132x132

    AI Redefines What’s Possible in Life Sciences

    Artificial intelligence (AI) technology has become pivotal in mainstream health care. The influx of big tech firms collaborating with incumbent life sciences companies to develop AI-based medical devices indicates that this trend will continue at a rapid pace.

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  • 2021-bl-gcp-violations_132x132

    Good Clinical Practices and 5 Common GCP Violations in Clinical Studies

    Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions, including drugs, biologics, devices, and therapy protocols. These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. Good Clinical Practices (GCPs) provide a platform for the quality of the data and a unified standard for the conduct of clinical trials. Understand the most common issues cited in U.S. Food and Drug Administration (FDA) inspections of clinical trials, and know how to avoid them.

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  • 2021-bl-qarad_132x132

    Should Design and Life Cycle Management of an eIFU Solution Follow EN62304?

    Electronic distribution of instructions for use (eIFU) are becoming widely used among medical device manufacturers. Due to the increasing popularity, it is critical to understand eIFU within the context of regulations, particularly Europe’s new medical device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

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