Featured Articles

  1. A Risk-Based Approach To Quality Processes In Life Sciences 10/4/2022

    Learn how to embed risk-based thinking into quality efforts with an integrated risk management software. 

  2. 6 Steps To Simplify Software Validation 10/4/2022

    Six steps to reducing the time, pain, and expense of the software validation process while maintaining quality and safety.

  3. Best Practices For Life Science Quality Leaders To Manage And Mitigate Risk 10/4/2022

    Learn how to improve traditional risk management methods and tools and how AI can help in the identification and mitigation of risk.

  4. Achieving Next-Level Quality With Digital Technology In Manufacturing 9/30/2022

    Learn how a modern Manufacturing Execution System (MES) is using digital production records to help manufacturers regulated by the FDA improve their quality and efficiency goals.

  5. Digital Solutions For Combatting Counterfeit Med Devices And Pharmaceuticals 9/29/2022

    Learn how digital solutions and a modern ERP system can effectively combat counterfeit med devices and pharmaceuticals to improve patient safety and business performance.

  6. Modernizing Your Cell & Gene Therapy Manufacturing Operations 9/29/2022

    What requirements should cell and gene therapy developers meet to successfully bring innovative therapies to market?

  7. Applying Quality System Regulation (QSR) Best Practices To Improve Regulatory Compliance 9/20/2022

    QSR compliance can be complex, but it doesn’t have to be burdensome. Implementing these best practices will improve your regulatory compliance while producing a product ready for market.

  8. How Process Digitization Accelerates Northeast Scientific's FDA Compliance 9/20/2022

    Learn how Northeast Scientific digitized and integrated our quality and manufacturing processes to help obtain 510(k) clearance from the FDA for the first and only reprocessed laser atherectomy catheter in the history of reprocessing.

  9. 3 Ways To Improve QMS Documentation: Following International Standards 9/8/2022

    We share how to get the most out of documenting your quality management system that can also help you stick to ISO 9001 standards.

  10. 6 Best Practices For Enterprise Quality Management Solutions Implementation 9/8/2022

    While all enterprise software implementations are unique we share six best practices that will improve the likelihood of any successful quality management software implementation project.