Compliance Management White Papers & Case Studies

  1. Vaccine Fill Line Operations 11/24/2025

    Learn how adopting a harmonized, risk-based validation strategy across global sites can reduce operational readiness timelines and drive improvements in equipment effectiveness and regulatory compliance

  2. GMP Manufacturing Cycle Time Reduction 11/24/2025

    Identifying process redundancies and enhancing visual management allows manufacturers to stabilize workflows. These data-driven improvements can decrease operational variability by nearly 50%.

  3. Mold In Cleanrooms: A Persistent Threat And The Case For Proactive Bio-Decontamination 11/17/2025

    Learn how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.

  4. Contamination In The Shadows: Risks Lurking From Environmental Issues 11/17/2025

    Discover how science-based bio-decontamination strategies effectively eliminate invisible pathogens and rapidly restore facilities to operational safety following major infrastructure disruptions.

  5. Ringing The Alarm: Unified Data For GMP Annex 1 Compliance 11/12/2025

    Alarm monitoring can be more than compliance. Learn how unified data and real-time insights helped one pharma company unlock efficiency, predictive analytics, and a path to digital transformation.

  6. Build An AAV8 Platform: Lessons From A Collaborative Development Journey 11/5/2025

    Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.

  7. Improving Productivity And Purity In ADC Polishing 11/5/2025

    Discover how a CDMO achieved 40x productivity and 15% cost savings by switching to rapid cycling membrane chromatography for ADC polishing, which helped cut process time and buffer use.

  8. Simple Orchestration Of Multiple Unit Operations 11/5/2025

    Gain insight into how consolidating downstream operations into a single automated system can reduce footprint, cut processing time, and minimize manual errors to help teams work more efficiently.

  9. Enabling The Future Of Intensified Biomanufacturing 11/5/2025

    Process intensification demands smarter orchestration, real-time analytics, and scalable automation. Discover how digital infrastructure enables synchronized, compliant, and predictive biomanufacturing.

  10. Navigating Digital Transformation For Pharmaceutical CDMOs 10/31/2025

    Discover how CDMOs can modernize operations, safeguard data integrity, and improve audit readiness with practical strategies for connecting systems and reducing validation burdens.