Compliance Management Featured Articles

  1. 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.

  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. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Why Manual QbD Leads To Delays, Errors, And Ongoing Frustrations 10/24/2025

    Manual QbD methods slow timelines and increase risk. Learn how intelligent, digital frameworks are helping CMC teams improve quality, accelerate submissions, and meet rising regulatory expectations.

  10. New Guide Aims To Build Robust Framework For Digital Validation Tools 10/22/2025

    The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.