GxP Lifeline
  • 2020-bl-thumb-covid-19-and-fdas-response

    Weighing FDA's Response to the COVID-19 Pandemic

    The rapid global spread of the coronavirus caught many world governments and health authorities off guard. Gina Guido-Redden, co-founder and COO of Coda Corp USA, offers a comprehensive review of the how the U.S. Food and Drug Administration (FDA) has responded thus far to the pandemic under 21 CFR.

    Full story
  • 2020-bl-thumb-data-integrity-and-21-cfr-part-11

    How Harmonizing 21 CFR Part 11 and Data Integrity Delivers Higher Quality Products

    Complying with the many record and data management requirements for 21 CFR Part 11 and data integrity can be daunting. In this article, Matt Brawner, data integrity subject matter expert (SME) at Sequence Inc., explains how companies can integrate Part 11 and data integrity processes to accelerate pathways to approval and deliver higher quality products to market.

    Full story
  • 2020-bl-thumb-well-controlled-clinical-trials

    How to Conduct a Well-Controlled Clinical Trial

    Successful clinical trials are a critical stage in the product life cycle of any life sciences product. Brandy Chittester, president of IMARC Research, outlines how manufacturers can conduct well-controlled trials that meet regulatory compliance and delineates pharmaceutical trials from those of the medical device industry.

    Full story
  • 2020-bl-thumb-med-device-ebook

    A Data-Centric Approach to Propel the Future of Device Innovation

    Technology and digital transformation are rapidly altering the way medical device manufacturers accelerate production and innovate new products. A new e-book “Mastering Data to Drive Medical Device Innovation to 2030” looks at how the medtech ecosystem is moving toward a more data-centric approach to quality manufacturing. Automated solutions integrated into a digital platform offer device makers the tools to generate real-time intelligence and insights that will lead to greater innovation over the next decade.

    Full story
  • 2020-bl-thumb-life-sciences-trends-point-spotlight-data

    2020 Life Sciences Industry Trends Point Spotlight on Data

    Data is taking on a prominent role in advanced technologies, which is rapidly changing the dynamic of innovation across all industries. A new MasterControl trend brief, “2020 Trends in Quality Data Management and Integrity for the Life Sciences,” examines new life sciences industry trends that pivot around data and how they will impact regulated companies.

    Full story
  • 2020-bl-thumb-brandwood-fda-501k-trends

    What 2019 Data Reveals About FDA’s 510(k) Program

    The U.S. Food and Drug Administration's (FDA) 510(k) pathway for medical devices is aimed at simplifying and instilling more predictability in the regulatory process. This article examines 2019 data on manufacturers’ use of the regulatory pathway and looks at some trends and takeaways for device makers.

    Full story
  • 2020-bl-thumb-your-map-to-quality-manufacturing-ripple

    Your Map to Quality Manufacturing

    Your path to quality manufacturing is simple: eliminate paper production records and digitize your shop floor. Follow these steps to achieve results that matter and drive revenue.

    Full story
  • 2020-bl-thumb-manufacturing-tech-trends-accelerate-time-to-market

    3 Trends That Can Improve Manufacturers’ Speed to Market

    Technologies are evolving and maturing, and regulatory bodies are reacting to remove unnecessary roadblocks for device companies while protecting consumer safety. Manufacturing organizations that embrace these opportunities will be better positioned to achieve significant efficiencies in product discovery and development, regulatory compliance and, ultimately, speed to market.

    Full story
  • 2020-bl-thumb-3-main-barriers-to-connected-quality

    3 Main Barriers to Connected Quality and How to Overcome Them

    Shrinking margins, intensifying competition and rapidly increasing product personalization and customization are complicating new product introduction pipelines in the life sciences. Leveraging the data connectivity capabilities of platforms is the key to overcoming these and other obstructions to a connected quality life cycle.

    Full story
  • 2020-bl-humb-fda-trending-toward-cloud-technology

    FDA Trending Toward Cloud Technology to Drive Innovation

    The life sciences industry is experiencing a surge of scientific and technology advances. However, there remains a sizeable gap between the discoveries and the technologies needed to translate them into useful therapies. Recently, the U.S. Food and Drug Administration (FDA) introduced a Technology Modernization Action Plan (TMAP) to foster modernization in the life sciences industry in order to more efficiently expedite scientific innovation.

    Full story
  • 2020-bl-thumb-how-to-increase-the-value-of-your-supplier-audits

    How to Increase the Value of Your Supplier Audits

    A manufacturer’s ability to maintain high-quality products and regulatory compliance depends largely on its suppliers’ own quality-related activities. Leveraged correctly, supplier audits can be an important tool that gives manufacturers greater visibility into these activities, according to Quality Support Group CEO Angelo Scangas.

    Full story
  • 2020-bl-thumb-gain-competitive-edge-with-iso-certification

    How Companies Gain a Competitive Edge With ISO Certification

    The International Organization of Standards (ISO) is a global organization that defines essential requirements for helping businesses improve their products, services and customer relations. Applying these guidelines enables organizations to give their customers the assurance that their products and services are safe, reliable and of good quality. This article introduces the most popular ISO standards and discusses how companies can use them to gain a competitive edge in their markets.

    Full story
  • 2020-bl-thumb-working-together-to-beat-covid-19

    Working Together to Beat COVID-19

    At this point, COVID-19 has touched everyone’s life in some way. While we’re still struggling to keep up with the pandemic, many of our customers are undergoing initiatives to test and/or treat the virus.

    Full story
  • 2020-bl-thumb-gamp-for-risk-based-computer-validation

    Leveraging GAMP 5 Compliance for Risk-Based Software Validation

    In a life sciences industry that highly values risk reduction, Good Automated Manufacturing Practices (GAMP) principles offer key insights on computer validation. GAMP 5 offers companies guidelines that can help ensure greater computer system compliance that reduces risk.

    Full story
  • 2020-bl-thumb-3-spock-quotes-for-manufacturing

    3 Spock Quotes for Manufacturing

    In honor of Leonard Nimoy’s birthday, we’ve taken some of Spock’s words of wisdom and applied them to manufacturing. Because it’s only logical to get paper off the shop floor and fully digitize your processes.

    Full story
  • 2020-bl-thumb-8-system-requirements-ext-quality-across-ecosystems

    8 System Requirements for Extending Quality Across Expanding Ecosystems

    More and more life sciences companies are adopting asset-light models that heavily rely on a broad system of contract organizations. When supply chains expand, however, quality is often the first casualty. Learn the key questions to ask to ensure your system can enforce quality across the entire ecosystem.

    Full story
  • 2020-bl-thumb-5-most-important-things-quality-system-management

    5 Essentials to Effectively Manage a Quality System

    In the life sciences and other regulated industries, effective quality system management is essential. Companies can’t deliver a safe and effective product and comply with regulators without one. But it’s also crucial that companies take a risk-based approach to selecting and developing a quality system that's well suited to their needs. Digital QMS solutions often offer unsurpassed benefits that a paper-based system can’t deliver.

    Full story
  • 2020-bl-thumb-coronavirus-global-supply-chain-risk

    "How Coronavirus, Brexit and Hurricanes Are Impacting the Global Supply Chain"

    Coronavirus is the newest in a string of natural and man-made disasters and events disrupting the global supply chain. Governments and the private sector need to take a collaborative risk-management approach to planning measures to confront pandemics and other events that threaten the stability of global supply chains and our ability to meet ensuing demand.

    Full story
  • 2020-bl-thumb-gartner-reprint-supply-chain-pharma-medtech

    How Healthy Is Your Supply Chain?

    Life sciences supply chains are unique. Pharmaceutical and medical device are even more so. Finding out industry standards and how your supply chain can improve are important questions that should be answered by the experts. Gartner recently produced “Supply Chain Benchmarking Data Reveals Differences Between Pharmaceutical and Medical Device Manufacturers” to provide those insights.

    Full story
  • 2020-bl-thumb-build-quality-into-production

    How Digital Production Records Can Build Quality Into Production

    Despite the investments that manufacturers have made in core digitization and automation, many producers stop short of digitizing their production records and other shop floor data collection efforts. The shop floor is a critical, but often overlooked, opportunity to make quality proactive rather than reactive. Every operator, step and output of the production process is a chance to establish quality and compliance – but only if operators have the tools to deliver quality at the source.

    Full story
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]