Insights On Quality Assurance

  1. Bridging The Gap Between Method Design And Execution In Analytical Development 11/12/2025

    Discover how a unified digital approach to analytical method development reduces compliance risk, improves visibility, and accelerates execution through structured data, protocol-driven workflows, and integrated performance insights.

  2. Lessons Learned From Implementing The FDA's CSA Guidance: Summarizing 8/20/2024

    Companies adopting CSA methodologies are not achieving the efficiencies they expected from the new guidance. This series identifies issues found during CSA implementations and how to avoid them.

  3. Maximize Operational Readiness And Efficiency Without Compromising Quality 12/12/2025

    Discover how digital transformation drives efficiency, agility, and compliance in pharmaceutical manufacturing to optimize processes, improve quality, and accelerate time-to-market.

  4. Advanced Aseptic Filling Assembly Helium Integrity Testing 10/15/2025

    Helium leak testing offers unmatched sensitivity for detecting micro-leaks in single-use fill-finish systems. Learn how tighter leak thresholds can strengthen aseptic processing and regulatory confidence.

  5. The GxP Digital Maturity Model 8/8/2025

    Explore how the GMP Digital Maturity Model guides life sciences companies through five stages to improve compliance, efficiency, and profitability with strategic digital adoption.

  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. Cell And Gene Therapy Innovations 5/19/2025

    This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.

  8. The Critical Role Of Product Inspection Systems In Manufacturing 4/21/2025

    Explore the vital role of product inspection systems in manufacturing as well as learn how checkweighers, metal detectors, and x-ray inspection ensure quality and safety across various industries.

  9. What Is A Bowie-Dick Test And Its Importance For Sterility Assurance? 11/26/2025

    Bowie-Dick testing ensures steam sterilizers remove air and achieve full steam penetration. Discover why this simple check is vital for compliance, safety, and preventing costly sterilization failures.

  10. Normalized Data In Microbial Continuous Monitoring 7/24/2025

    Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.