GxP Lifeline

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    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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    5 Ways Digital Technology Will Transform the Supply Chain

    Digital transformation initiatives were already underway among life sciences manufacturers before COVID-19 struck, but the volatility around the global pandemic brought to light the importance of digital technologies in the supply chain. Research indicates that companies digitised many activities 20-25 times faster as a result of COVID-19. Integrating digital technologies in the supply chain has enormous implications for life science organisations.

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    How Electronic Batch Records and Device History Records Close the Digital Manufacturing Gap

    To support advanced data technologies and to compete in a modern market, manufacturers must close the digital gap on the shop floor, where critical production processes remain paper-based and disconnected. Digitizing the paper-based production record process can close this gap by creating productive connections between people, processes, and systems throughout the manufacturing process and across the entire enterprise for a holistic view of production data.

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    5 Ways Paper-Based Processes Hinder Financial Success

    If you haven't digitized yet, it's hurting the bottom line. As reported by Deloitte, digitally mature companies are, "about twice as likely as lower-maturity ones to report net profit margins an annual growth significantly above their industry average." Here's a look at five critical ways that paper-based processes are eating into revenue.

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    The Role of Supply Agreements in Life Sciences Manufacturing

    In light of the COVID-19 pandemic’s disruption to the global supply chain and the urgency around manufacturers quickly delivering life-saving products, it makes sense that manufacturing organisations and their supply partners might reassess their relationships and obligations to one another to manage the results of disruption to supply chain partners.

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    A Risk-Based Approach to Supplier and Vendor Audits

    A manufacturer’s ability to deliver high-quality products and maintain regulatory compliance relies in part on the quality-related activities of its own suppliers and vendors. Supplier and vendor audits can be important tools for manufacturing organisations to ensure their suppliers and vendors aren’t the source of major issues in product parts or materials. Digitisation can dramatically enhance supplier audits and vendor qualification audits in a number of ways.

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    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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    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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    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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    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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    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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    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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  • Measuring Risk Management Outcomes

    The task of measuring the benefits risk management brings to an organization is a challenging one. To overcome this challenge, the measurement of risk management performance needs to consider a wide range of factors.

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  • Quality Is the Key Ingredient to Successful Manufacturing

    The president of Wellington Foods, a leading contract manufacturer of nutraceuticals, explains why quality should be an organization’s top priority. This approach helps manufacturers achieve better process control and plan for significant growth without worrying about highly complex manufacturing processes.

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    The Future of Quality Is Artificial Intelligence

    Artificial intelligence (AI) isn’t just a cool tech trend. At the rate it’s going, it’s shaping the future of quality in the life sciences. Which is why we’ve designed a new data analytics solution that gives users complete control over their data and uses AI to drive decision-making.

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  • Future Trends and Opportunities in Quality Assurance

    At a previous PDA/FDA Joint Regulatory Conference in Washington, D.C, Donna Gulbinski, quality and regulatory affairs expert, provided useful information about the future of quality management. She identified some key strategies for how your organization can identify and understand quality assurance trends and develop initiatives for long-term success.

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    Three Quality Management Trends to Watch in 2021

    Three key trends in MedTech quality management for 2021 include a rise in eQMS adoption, the continuation of remote audits and an increase in shared supplier audits.

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    EU’s MDR Calls for Summary of Safety and Clinical Performance (SSCP)

    With the fast-approaching Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device manufacturers will be seeing more documentation requirements. One of the new documents is a summary of safety and clinical performance (SSCP). This is one of the annual reports manufacturers must provide throughout the life cycle of a device in order to remain compliant to sell products in the EU.

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    The Next Evolution in Manufacturing

    On 30 July 2020, we celebrated the 17th anniversary of the completion of the Human Genome Project (HGP). It took scientists 13 years to map and sequence all human genes, a staggering feat of modern science.

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    What Connected Quality Means for Training

    For regulated companies, there’s a whole lot riding on training. If someone isn’t trained or is trained improperly, the life-saving products of life sciences companies can become life-ending products.

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