Featured Articles

  1. How To Avoid Warning Letters For Data Integrity Nonconformances In Life Sciences 11/10/2022

    Data integrity is established where the data is stored and managed in its original form. Discover why the FDA expects manufacturers to ensure all data meets the guidelines outlined in the ALCOA acronym.

  2. Eliminating Data Integrity Errors Through Digitization 10/17/2022

    Explore the urgent need for businesses to adopt strong data integrity practices and identifies measures for how to achieve and sustain compliance.

  3. How To Improve CAPA Metrics 10/13/2022

    A CAPA management system can provide your company with the ability to recognize and correct risks. Learn how to ensure your CAPA management system benefits the manufacturing process.

  4. 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. 

  5. 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.

  6. 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.

  7. 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.

  8. 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?

  9. 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.

  10. 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.