Validation, Commissioning & Design Featured Articles

  1. 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.”

  2. 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.

  3. 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.

  4. 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.

  5. How AI-Enhanced CAPA Systems Actually Work 11/6/2025

    Learn how AI can accelerate root cause analysis, predict quality risks, and streamline CAPA without compromising compliance or overwhelming your team with practical strategies.

  6. 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.

  7. Discover How Our Polyurethanes Can Enhance Your Medical Device Designs 10/31/2025

    Medureon™ is a family of medical-grade polyurethanes engineered for high performance, biocompatibility, and reliability in advanced, critical medical device applications.

  8. 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.

  9. 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.

  10. How To Mitigate Particulate Contamination In cGMP 10/28/2025

    Maintaining cGMP standards, controlling particulate contamination ensures drug safety, quality, effectiveness, and shelf life while preventing immune reactions and regulatory noncompliance.