• 2020-bl-thumb-cmo-trend-brief_132x132

    3 Ways CMOs Are Looking to Digital Technology to Improve Collaboration

    Rising demand for contract manufacturing organizations (CMO) necessitates growth to new locations throughout the U.S. and across the globe. The result of this expansion is increased production, but also a more complex supply chain, which requires digital collaboration with brand owners.

    Full story
  • 2020-bl-thumb-lean-manufacturing_132x132

    The AI Approach to Lean Manufacturing

    Like many great ideas, lean manufacturing is a seemingly simple idea that proves very difficult to implement. Its shortest definition is doing something in the most efficient, least wasteful way. Sounds simple, but when you get into the details, things can get complicated. That’s where data comes in.

    Full story
  • 2020-bl-thumb-three-c-in-covid-19

    Three C’s That Will Matter for Manufacturers in a ‘Post-COVID-19’ World

    The time for manufacturers to prepare for a post-COVID-19 world is now. Re-calibrate for the "new normal" by looking to these "three c's" for guidance.

    Full story
  • smart-document-contract-132

    FDA 21 CFR Part 11 and Predicate Rules: What You Need to Know

    Through FDA 21 CRF Part 11, the U.S. Food and Drug Administration (FDA), established that electronic records and signatures are as valid as paper records and handwritten signatures. Maintaining compliance is dependent on your understanding of the FDA predicate rules that apply to your company.

    Full story
  • 2020-bl-thumb-3-advantages-data-centric-quality-mindset

    3 Advantages of a Data-Centric Quality Mindset

    A seismic shift is coming to life sciences manufacturing, and that’s the move from documents to data. With a data-centric mindset, it’s possible to glean valuable insights while gaining a tremendous competitive advantage.

    Full story
  • 2020-bl-thumb-mx-ultimate-guide

    How Electronic Production Records Can Extend Manufacturers’ Digital Edge

    Even as manufacturers invest in system digitization and automation, the people responsible for production records have been left to manage paper, spreadsheets and other standalone systems to collect, record and interpret data relating to production and quality processes. By extending digitization beyond their core systems to their production records, manufacturers can gain a more complete view of their data, optimize manufacturing and ensure quality throughout the production life cycle.

    Full story
  • 2020-bl-thumb-supply-chain-automation-and-ml

    4 Steps to Integrate Technology Into Your Pharma Supply Chain

    An array of advanced technology and digitization are rapidly changing the landscape of pharmaceutical manufacturers and their supply chains. Mukul Dakwale, principal consultant at Luceats, explains how formulating a digitization strategy and implementation plan can help your pharma company transition from disparate, manual data systems toward end-to-end automation.

    Full story
  • 2020-bl-thumb-minimalism-threatens-quality

    Overcoming Minimalism to Elevate Manufacturing Quality

    The philosophy and cultural of minimalism and “settling” can be disadvantageous when it comes to quality manufacturing standards and expectations. Jim Leonard, a senior consultant with QSG, presents quantitative and qualitative analysis of how such approaches can stagnate quality and shares tips on how to achieve a high level of continuous improvement in manufacturing.

    Full story
  • 2020-bl-thumb-qserveeu-mdr-update

    EU's MDR Extended: Where Do Medical Device Manufacturers Stand?

    The much-anticipated one-year delay of the European Union’s Medical Device Regulation (MDR) finally dropped earlier this month. Gert Bos, Executive Director and Partner of the Qserve Group, breaks down what this means for device manufacturers and for their preparations to recertify under the new regulation through a designated Notified Body.

    Full story
  • 2020-bl-thumb-masters-conference-covid-thank-you

    A Heartfelt Thank-You to Our Customers

    In response to COVID-19, our customers and so many others are working hard on the front lines, behind the scenes, and everywhere in between. From everyone at MasterControl: Thank you!

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