Quality Featured Articles

  1. Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities 8/1/2025

    In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.

  2. Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance 7/28/2025

    Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.

  3. Ensuring AI Compliance In Life Sciences: 5 Critical Requirements 7/24/2025

    Life sciences manufacturers face growing pressure to adopt AI while staying compliant. Discover five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.

  4. How To Solve The Big Challenges Of Cell And Gene Therapy Manufacturing 7/24/2025

    Cell and gene therapies are revolutionizing medicine, but outdated manufacturing methods are slowing progress. Discover how modernizing CGT production can unlock the full potential of life-changing treatments.

  5. Why Established Pharma Sites Need A Digital Cleaning Validation Strategy 7/23/2025

    Pharmaceutical facilities face mounting pressure to modernize. Uncover how digital tools are transforming cleaning validation to boost compliance and audit readiness without disruption.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.