• Remote Audits Reignite Regulated Companies and Supply Chains

    2 July, 2020 By David Jensen Staff Writer, MasterControl

    The COVID-19 pandemic disrupted many aspects of global societies, lifestyles and economies. Fortunately, technology has enabled the regulatory industry to continue functioning by conducting audits remotely. In this article, Derek Churchill, senior consultant at Quality Support Group (QSG), explains how remote audits work and how companies can prepare for this new type of audit.

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  • Having a Good Quality Culture Improves Your Data Integrity

    30 June, 2020 By Susan Schniepp, Distiguished Fellow at Regulatory Compliance Associates, Inc

    Data integrity is a high priority to both the pharmaceutical industry and regulatory authorities. To improve data integrity, it's critical to example the role of quality in your company culture.

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  • Chronicles of a Document Control System

    26 June, 2020 By David Jensen Staff Writer, MasterControl

    Regulated companies are often reminded that if it isn’t documented, it didn’t happen. It’s also safe to say if it is documented, but the documents can’t be found, it didn’t happen. An efficient document control system is at the core of quality management and good manufacturing practices.

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  • What Verification and Validation Activities are Required for a First in Human Study?

    23 June, 2020 By Lynessa Erler, Director of Product Testing at MPR Associates, Inc.

    Manufacturers preparing for a first in human (FIH) study of a new medical device face questions. Learn answers about what verification and validation activities are required for a FIH study.

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  • Industry 5.0: Top 3 Things You Need to Know

    19 June, 2020 By James Jardine, Staff Writer, MasterControl

    Whether you like it or not, you should brace yourself for Industry 5.0. The term refers to people working alongside robots and smart machines. If that definition brought to mind the image of Will Smith battling evil robots in the movie “I, Robot,” here are a few things you need to know about Industry 5.0.

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  • 3 Ways CMOs Are Looking to Digital Technology to Improve Collaboration

    18 June, 2020 By Dale Thompson Staff Writer, MasterControl

    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.

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  • The AI Approach to Lean Manufacturing

    17 June, 2020 By Sarah Beale Staff Writer, Master Control

    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.

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

    16 June, 2020 By Rai Chowdhary, CEO of KPI System (Key Performance Improvement)

    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.

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

    11 June, 2020 By James Jardine, Staff Writer, MasterControl

    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.

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  • The Platform Advantage: Keys to Keeping Up With Pharma’s Top 4 Trends

    9 June, 2020 By James Jardine, Staff Writer, MasterControl

    Software platforms are revolutionizing the quality function. What was once a guardrail for pharmaceutical and biotech companies is rapidly becoming a business accelerator that provides quantifiable competitive advantages. Discover how game-changing platforms are empowering leading companies to adapt to four predominant pharma industry trends by streamlining the management of data and quality processes.

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  • 3 Advantages of a Data-Centric Quality Mindset

    4 June, 2020 By Dale Thompson, Staff Writer

    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.

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  • How Electronic Production Records Can Extend Manufacturers’ Digital Edge

    2 June, 2020 by David Butcher

    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.

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  • 4 Steps to Integrate Technology Into Your Pharma Supply Chain

    28 May, 2020 by Mukul Dakwale, Principal Consultant, Luceats Consulting

    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.

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  • Overcoming Minimalism to Elevate Manufacturing Quality

    27 May, 2020 by Jim Leonard, Senior Consultant, QSG

    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.

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

    26 May, 2020 by Gert W. Bos, PhD, Fraps, Executive Director and Partner, the QServe Group

    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.

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  • A Heartfelt Thank-You to Our Customers

    20 May, 2020 From Everyone at MasterControl

    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!

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  • Weighing FDA's Response to the COVID-19 Pandemic

    19 May, 2020 by Gina Guido-Redden, Co-Founder and COO, Coda Corp USA

    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.

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

    14 May, 2020 by David Jensen, Staff Writer, MasterControl

    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.

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

    12 May, 2020 by Mike Rigert, Staff Writer, MasterControl

    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.

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  • How to Conduct a Well-Controlled Clinical Trial

    7 May, 2020 Brandy Chittester, President, IMARC Research

    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.

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