• FDA Sets Out to Curb Data Integrity Violations With Guidance on Data Handling

    7 August, 2020 by David Jensen, Staff Writer, MasterControl

    Noticing an increase in violations of current good manufacturing practices (CGMP) regarding data integrity, the U.S. Food and Drug Administration (FDA) drafted a question-and-answer-based guidance to address some of the frequently asked questions and to clarify the role of data integrity in regulated product manufacturing.

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  • Digitization Enhances Rather Than Replaces Workers

    6 August, 2020 by Dale Thompson Staff Writer, MasterControl

    Automation and digitization are rapidly becoming the norm for life sciences companies. While some people are concerned new technologies will replace workers, Mike Ferletic, President and CEO of Enterey, believes the opposite.

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  • ISO 9001 in the Time of COVID-19

    4 August, 2020 by Sarah Beale, Staff Writer, MasterControl

    Companies that were prepared with good quality management have fared better during the pandemic. ISO 9001 in particular has proved inadvertently helpful in adapting to disruption. To see how ISO connects to COVID-19, we spoke to Debby Newslow of D.L. Newslow & Associates.

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  • The Next Evolution in Manufacturing

    30 July, 2020 by Sarah Beale, Staff Writer, MasterControl

    There’s no reason to keep living in the past when it comes to your batch review process. With review by exception, you can accelerate your processes to get product out the door faster. All while reducing frustration in both quality and manufacturing.

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  • Industry 5.0: Top 3 Things You Need to Know

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

    29 July, 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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  • COVID-19 Highlights Need for Flexible, Paperless Manufacturing Processes

    28 July, 2020 by David Butcher, Staff Writer

    The pandemic has highlighted the need for a faster, more flexible and scalable manufacturing environment that balances speed with compliance. While paper-based processes can slow production down or jeopardize quality, paperless production processes can streamline operations, reduce errors and readily leverage data critical to ensuring quality. A configurable, purpose-built electronic device history record (eDHR) application can be fast to implement and deliver quantifiable benefits.

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  • 3 Quality Metrics Improved By Paperless Manufacturing

    27 July, 2020 By David Butcher, Staff Writer, MasterControl

    A digital gap remains between quality assurance and manufacturing operations, as people on the production line still rely on paper-based production records and spreadsheets. This gap has left manufacturers susceptible to data entry errors, long good quality review times, shipment delays and other paper-based challenges. A paperless approach can deliver measurable results that have a notable impact on manufacturing operations, product quality and the bottom line.

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  • Avoiding a Time Traveler’s Mindset With Effectiveness Checks

    27 July, 2020 by Sarah Beale, Staff Writer, MasterControl

    How many times have you done something and immediately wished you could undo it? Or how many times have you wished you knew the outcome of something beforehand? Since time travel still eludes us, the best we can hope for is to try to fix our mistakes and anticipate future ones. In the regulated industry this is called corrective and preventive action (CAPA).

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  • Digital Tools to Streamline Supplier Management Processes

    24 July, 2020 By David Butcher Staff Writer, MasterControl

    The global COVID-19 pandemic has forced many manufacturers to re-examine how they manage their supply chains. Amid large-scale shocks to supply and demand, manufacturers and their supplier partners must balance speed with quality, without putting their own employees at risk or adding significant costs. Now is the time to. Leveraging digital supplier management tools can help manufacturers streamline supplier processes like audits and inspections without the on-site threat to employees and vendors and unnecessary travel costs.

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  • 5 Helpful Quality Event Management Tips From a CAPA Pro

    22 July, 2020 By James Jardine, Staff Writer, MasterControl

    Expert consultant, Ken Peterson, offers best practices for quality event management systems (QMS) that will help you avoid “death by CAPA.”

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  • Software as a Medical Device – Upcoming Changes to the Australian Regulations

    17 July, 2020 by Belinda Dowsett, Quality Assurance Manager and Consultant

    So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.

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  • SPC vs SQC: The Strategic Difference

    17 July, 2020 By Jason Orloff, Statistical & Engineering Consultant, Pharmstat

    The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).

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  • Our Expert Weighs in on Platforms, Data and AI

    16 July, 2020 by Sarah Beale, Staff Writer, MasterControl

    MasterControl Product Management Director Sue Marchant sat down with GxP Lifeline to talk about our platform approach, why that’s important and how it can eventually lead to artificial intelligence (AI) applications for our customers. She also gave us a sneak peek at what to expect in the next generation of MasterControl products.

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  • Nelson Labs on Adaptability and Communication in the Time of COVID-19

    15 July, 2020 by David Butcher, Staff Writer

    Nelson Laboratories, a global provider of microbiological and analytical laboratory testing, is one of the many companies making an impact in the protective barriers area during the pandemic. The Salt Lake City-based company is heavily involved in testing the efficacy of facemasks and respirators. In a recent interview, Nelson Labs President Jeffrey R. Nelson spoke on what it has taken to achieve 24/7 coverage while maintaining quality and protecting employee health.

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  • Mind the Gap! The 3 Biggest Gaps Faced When Implementing IVDR

    13 July, 2020 by Sue Spenser, Head of IVD and Principal Consultant, Qserve

    If you are preparing to implement IVDR, there are specific gaps that are easily missed. Ensure the intended purpose is clear, risk management issues have been addressed, and pay close attention to details.

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  • Four 2019 Manufacturing Batch Record Trends Holding Up in 2020

    10 July, 2020 Dale Thompson, Staff Writer, MasterControl

    Manufacturing batch record trends from 2019 have picked up speed in 2020. Now is the time to focus on becoming data-centric, move to digital batch records, utilize the potential of workers on the shop floor, and create a truly paperless manufacturing environment.

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  • Global 2020 Cannabis Trends

    9 July, 2020 Sarah Beale Staff Writer, MasterControl

    Cannabis is legally and socially becoming more accepted worldwide. New regulations, new products and new technology are all helping the cannabis industry mature. In 2020, these trends are expected to shape the industry.

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  • 2019 Nutraceutical Trends: Relevant During COVID-19

    8 July, 2020 By Sarah Beale, Staff Writer, MasterControl

    Five major trends hit nutraceuticals last year. For the most part, those trends played out as expected. What was not expected was for the year to end in the COVID-19 pandemic. We’d like to take a look at how the pandemic has changed last year’s trends and what the future likely holds for the nutraceutical industry.

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  • How to Align Quality Across an Expanding Ecosystem

    7 July, 2020 By James Jardine, Staff Writer, MasterControl

    As companies grow more reliant on geographically dispersed contractors, partners, vendors and business units, it gets harder to align quality across all the entities involved. Learn how global companies like Fagron maintain quality consistency across multiple sites and discover why connecting data and processes within a robust digital platform is the surest way to align quality across your entire ecosystem.

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