Quality Featured Articles

31. 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.

32. 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.

33. 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.

34. 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.

35. 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. 

36. Why The Latest E2500-25 Standard Revision Demands Immediate Action 9/14/2025

    The updated E2500-25 standard transforms pharmaceutical manufacturing with a proactive, risk-based approach, enhancing compliance and accelerating the delivery of therapies to patients.

37. 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.

38. 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.

39. 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.

40. Advancing Drug Product Quality Through AVI And Future-Ready Infrastructure 9/5/2025

    Automated visual inspection (AVI) combines robotics, precision imaging, and sophisticated defect-recognition software to provide a scalable solution for expanding pipelines and rises in production volumes.