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GxP Lifeline

Showing items tagged as Software

  • 2022-bl-software-validation_132x132

    6 Steps to Simplify Software Validation

    The FDA requires companies to validate software used in regulatory environments. But the processes involved in validation are usually a drain on your time and resources. By following six fundamental steps, you can adopt and validate software systems with greater ease.

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  • factory-engineers-quality-assurance-132

    Top 5 Manufacturing Shop Floor Safety Tips

    Optimizing shop floor safety practices is as straightforward as abiding by five fundamental manufacturing safety tips. Learn how the right ideology can enable a manufacturer to establish effective shop floor safety practices and extend a safety-centered mindset across the entire enterprise.

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  • 2019-bl-thumb-new-european-mdr-regulation-how-will-affect-software

    EU MDR: How Will Europe’s New Device Regulation Affect Software?

    The European Union’s Medical Device Regulation (MDR) will replace the older Medical Device Directive beginning in May 2020. While this is presenting new regulatory challenges to device makers, medtech companies also need to consider how MDR will impact their production data and software systems. Companies that are well-prepared and have a robust quality management system will be best positioned to implement the new regulation.

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  • 2018-bl-thumb-top-5-med-device-industry-trends-software complex

    Top 5 Medical Device Industry Trends in 2018: Software Is More Common and Complex

    The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.

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