Validation, Commissioning & Design Featured Articles

  1. Process Validation For Pharmaceutical Manufacturers 9/18/2025

    Manufacturers must validate their processes to meet FDA standards and protect consumer safety. Explore how process validation ensures consistent product quality and is a cornerstone of compliance.

  2. Navigating Technology Transfer In Manufacturing 9/18/2025

    Technology transfer is essential for scaling life sciences innovation. Learn how teams navigate its complexity, overcome common challenges, and leverage digital tools to improve quality.

  3. Tips For Tracking And Recreating Your Golden Batch 9/18/2025

    Discover how pharmaceutical manufacturers are using digital tools to achieve the “golden batch”—a production run that balances quality, efficiency, and compliance through smarter processes.

  4. Computer Software Assurance: A Game-Changer For Life Sciences Compliance 9/18/2025

    CSA offers a smarter, risk-based approach to software validation that reduces documentation burdens while enhancing product quality. Learn how teams are using it to accelerate digital transformation.

  5. Take Action On PFAS To Protect Your Critical Processes 9/18/2025

    PFAS restrictions are tightening, but a full ban could disrupt critical industries lacking alternatives, such as pharmaceutical manufacturing. Learn where PFAS use remains indispensable.

  6. 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.

  7. 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.

  8. 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. 

  9. 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.

  10. 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.