Featured Articles

  1. Continuous Improvement In Life Science Manufacturing 11/15/2022

    Learn how having a 6S program tethered to a hierarchy of needs will provide safety for your team when introducing new lean manufacturing processes or continuous improvement software.

  2. 6 Core Capabilities Your Digital DHR Must Have 11/14/2022

    In medical technology manufacturing, organizations must maintain complete and accurate device history records (DHRs). For those manufacturers regulated by the U.S. Food and Drug Administration (FDA), the agency has made it clear. If the DHR doesn’t include complete information relating to the production and control of each lot or batch, the medtech manufacturer risks product quality issues or worse. Between 2017-2021, DHRs were among the top medical device warning letters issued by the FDA.

  3. Best Practices When Shifting From Paper To Digital Logbooks 11/10/2022

    For companies developing regulated products, explore why everything that happens to equipment must be appropriately documented to maintain compliance with current good manufacturing practices (cGMP).

  4. 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.

  5. 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.

  6. 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.

  7. 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. 

  8. 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.

  9. 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.

  10. 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.