Validation, Commissioning & Design Featured Articles

  1. Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation 9/17/2025

    Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.

  2. Test Kit Management: The Hidden Weak Point In Your Visual Inspection Program 9/17/2025

    A proper test kit management program is no longer a “nice-to-have”—it’s a compliance necessity. Without a structured system, you risk inspector drift, failed audits, and errors in batch release.

  3. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

    Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

  4. What Are PFAS And How Do They Impact The Biotech Industry? 9/13/2025

    Forever chemicals pose rising health risks and regulatory challenges. Learn how increasing restrictions on fluorinated compounds could reshape manufacturing, packaging, and sustainability strategies.

  5. How Non-Destructive Headspace Analysis Advances CCI Testing 9/13/2025

    Opting to use headspace analysis to assess container closure integrity (CCI) for your drug packaging ensures robust data and CCI assurance to protect your product and maintain regulatory compliance.

  6. A Direct Path To Annex 1 Compliance With Blow/Fill/Seal Technologies 9/13/2025

    Learn how Blow/Fill/Seal technology supports contamination control, reduces operator risk, and meets sterility assurance requirements under dynamic conditions with advanced airflow and monitoring.

  7. Protecting CAPEX Budgets Through Digital Validation 9/9/2025

    Streamline your CAPEX validation to accelerate growth, reduce costs, and bring your product to market faster. Discover how futureproof digital validation can protect your budget and maximize value.

  8. How Digital Procedures And E-Logbooks Are Transforming Manufacturing 9/2/2025

    Paper-based processes slow down life sciences manufacturing and introduce compliance risks. Discover how digital procedures and electronic logbooks can boost accuracy, speed, and traceability.

  9. The Rising Cost Of Product Recalls In Life Sciences 9/2/2025

    Product recalls are becoming a major concern in life sciences. Learn why your company must act now to strengthen quality systems and reduce risk across pharmaceuticals, devices, and biologics.

  10. Mastering Modern Recall Management: A 6-Part Journey To Excellence 9/2/2025

    Explore the rising challenges of recall management in life sciences. This six-part series offers expert insights and unveils a groundbreaking solution set to transform how companies manage recalls.