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GxP Lifeline

Showing items tagged as COVID-19

  • How to Meet FDA Remote Inspections Requirements with a Digitized QMS

    FDA Remote “Inspections” During the Pandemic

    Even during the pandemic, regulatory inspections must go on. The FDA favored some remote inspectional activities, but has not adopted remote inspections, per se. Mastering remote interactions with the FDA and remote audits require the same digital approach.

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  • Medical Device Manufacturing Digitization Trends and Best Practices with MasterControl Manufacturing Software

    Medical Device Manufacturing Trends, Part 1: Resilient Supply Chains Require Modern Tools

    While visibility, agility, and responsiveness have been priorities in managing supply chains for decades, the disruption and volatility around the COVID-19 pandemic amplified their critical role. In doing so, it brought to light the need to digitize and integrate supply chain systems to ensure all relevant data and insights can be connected for optimal resiliency. To protect themselves in the face of supply chain volatility, medical device manufacturers should reassess their supply chain capabilities with an eye toward proactive, tech-enabled solutions.

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  • 2021-bl-food-and-beverage_132x132

    Trends Redefining the Food and Beverage Industry

    The COVID-19 pandemic has been disruptive. At the same time, it has elevated consumers’ interest in pursuing healthier lifestyles, such as tracing food supply chains and consuming more immunity-boosting foods. This post examines new trends in the food and beverage industry and how manufacturers are adapting by implementing digitized technologies.

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  • 2021-bl-unlocking-your-data-potential_132x132

    3 Data Access Enhancements That Expedite Drug Development and Approvals

    Regulators began increasing focus on data accuracy long before the pandemic, but it’s a trend that’s only continuing to gain more momentum. Discover how data connectivity improvements are helping pharma companies align with regulatory dynamics and get drug products to market faster.

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    Rapid Acceleration in Technology for Life Sciences Quality and Manufacturing

    We have built technology for life sciences quality and manufacturing for more than 25 years and I have been involved in that effort for 19 years. It wasn’t until 2014 that we realized the why behind what we do and it wasn’t until 2020 that our mission became crystal clear to everyone on our teams.

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  • 2020-bl-alan-rencher-highlights_132x132

    How a Force Multiplier Elevates Your Organization’s Success

    At MasterControl’s Virtual Masters Summit 2020, vice president of engineering Alan Rencher provided valuable insight about force multiplication and how it gives companies the ability to seamlessly integrate business units, excel in all aspects of operations and sustain a competitive advantage.

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  • 2020-bl-managing-compliance-costs_132x132

    CLIA Certification: 3 Things You Need to Know

    Testing accuracy and reliability are the top priorities of any laboratory that conducts tests on humans. To demonstrate their commitment to testing integrity, facilities in the U.S. must adhere to Clinical Laboratory Improvement Amendments (CLIA) quality regulations. The path to CLIA certification begins by addressing three fundamental questions.

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    ISO 9001 in the Time of COVID-19

    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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