Insights On Quality Assurance

  1. The Benefits Of Automating Your Requirements Traceability Matrix 7/23/2025

    The Requirements Traceability Matrix ensures every system requirement is verified through testing, supporting compliance, reducing risk, and strengthening validation efforts across development.

  2. Biotech's Plastic Problem Meets Its Match 8/8/2025

    Explore how a partnership with UW–Madison and Genentech developed a breakthrough recycling technology that is poised to reshape single-use bioprocessing sustainability.

  3. Headspace Gas Ingress To Replace Dye Ingress CCI Testing 7/8/2025

    Explore a cutting-edge, non-destructive method for container closure integrity testing using CO₂ tracer gas and headspace analysis—an advanced alternative to traditional dye ingress techniques.

  4. Developing A Project Management Office (PMO) At A Small Manufacturing Site 8/11/2025

    Discover how implementing a Project Management Office transformed a small manufacturing site into a high-performing, strategic asset within a global network.

  5. The Role Of Quality By Design In Pharmaceutical Tablet Development 7/30/2024

    Quality by Design (QbD) ensures efficiency and high standards in pharmaceutical tablet development. Explore how this proactive approach transforms manufacturing processes and enhances product quality.

  6. Building A Connected Quality And Manufacturing Ecosystem In Life Sciences 12/27/2024

    Discover the transformative power of connected quality and manufacturing systems, offering strategies for digital transformation, enhanced efficiency, compliance, and real-world success in life sciences.

  7. Optimizing Contamination Control: Strategy Planning And Execution For Facility Compliance 7/25/2025

    A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

  8. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

    21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

  9. Container Closure Integrity Test Method Development For Autoinjectors 8/6/2025

    Discover an autoinjector technology that leverages laser-based headspace analysis for container closure integrity to advance biologic drug delivery with precision, safety, and regulatory confidence.

  10. ResDNASEQ Workflow Solution 5/22/2025

    Explore the Applied Biosystems resDNASEQ workflow solutions. Starting with the sample preparation kit, to purification, quantitating residual host-cell DNA, and analyzing resDNASEQ assays.