Quality Featured Articles

  1. Fostering A Quality Software Culture 11/24/2025

    Transforming the quality culture should include the adoption of software quality engineering (SQE), but what is it, and how can it impact the quality of your products and processes?

  2. Lessons In Quality From Sanofi's Plai.qa 11/24/2025

    The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.

  3. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

    A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

  4. Confessions Of A Microbiologist: What I Wish I Had Known For Our Facility Shutdown 11/17/2025

    Facility shutdowns often compromise contamination control strategies. Transitioning from manual cleaning to automated bio-decontamination ensures a more effective facility restart, eliminating persistent mold risks.

  5. How To Improve Sponsor–CMO Collaboration Around Digital Deviations 11/17/2025

    Digital strategies and standardized data models cut manual work, boost accuracy and speed of information sharing, and build trust between sponsors and CMOs.

  6. Operational Readiness Frameworks For Pharma And Biotech 11/14/2025

    Achieving top performance in life sciences requires a continuous journey from Operational Readiness (OR) to sustained Operational Excellence (OE), ensuring safe startup and long-term efficiency.

  7. Viral Vector Technology Transfers: A Guide To Success 11/13/2025

    Strategic, well-aligned partnerships between sponsors and CDMOs are key to efficient, scalable viral vector technology transfer.

  8. 3 Reasons Why Manufacturers And CDMOs Are Integrating QA, QC, And Manufacturing 11/5/2025

    Life sciences manufacturers are integrating QA, QC, and production to boost efficiency, reduce downtime, and scale smartly. Discover how Industry 4.0 technologies are reshaping operations.

  9. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

    The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

  10. Industrial DataOps: The Backbone Of AI-Ready Manufacturing Data 10/30/2025

    Manufacturers aiming for AI adoption often face data readiness challenges. Learn how Industrial DataOps helps transform raw data into usable insights, laying the groundwork for scalable operations.