Validation, Commissioning & Design Featured Articles

  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. Stop Managing CQV In Silos: Unify Your Validation Systems 7/23/2025

    Fragmented CQV systems hinder validation efforts, which risks compliance and slows progress. Discover how centralized platforms streamline processes, boost efficiency, and meet evolving regulatory demands.

  3. How Intelligent Automation Transforms CQV Workflows 7/23/2025

    Discover how intelligent automation is revolutionizing CQV in life sciences to eliminate manual bottlenecks, accelerate timelines, and enhance compliance in an era of increasing regulatory scrutiny.

  4. AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies 7/23/2025

    A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.

  5. Mitigating Risks In Sterile Injectable Manufacturing: How CMOs Can Ensure Product Safety 7/23/2025

    Sterile injectable manufacturing carries high risks. CMOs like Afton Scientific use rigorous quality systems, audits, and training to ensure patient safety, compliance, and product integrity.

  6. Contamination Control Strategies For Gene Therapy Manufacturing 7/23/2025

    Gene therapy manufacturing demands a careful balance between contamination control and efficiency. A strategic approach to “critical aseptic” designation is essential to meet evolving regulatory challenges.

  7. FDA Quietly Eases Nitrosamine Reporting Rules Ahead Of August Deadline 7/17/2025

    The FDA changed expectations for nitrosamine drug substance-related impurities reporting, accepting progress reports in lieu of full compliance. Here's what it means.

  8. Aiming For Success In Early mAb Process Development And Beyond 7/15/2025

    Developing a monoclonal antibody (mAb) requires strict quality compliance. Building on a strong foundation from the start with a quality by design (QbD) approach is key for success and minimizing variability.

  9. The Role Of CDMOs In Supporting Generic Drug Development 7/15/2025

    Bringing complex generics to market requires deep expertise. Learn how a CDMO can help navigate regulatory, technical, and commercial challenges with end-to-end development and manufacturing support.

  10. Building A High-Fidelity Manual Baseline For Tomorrow's Automated Inspection 7/14/2025

    Future-proof your pharma manufacturing. Discover why manual visual inspection remains foundational and how advanced software can build a high-fidelity baseline for automation success.