Validation, Commissioning & Design Featured Articles

  1. Building Trust In AI For Computerized System Validation 9/4/2026

    Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.

  2. When To Trust And When To Verify AI-Enabled Validation Systems 9/3/2026

    Computer software assurance, coupled with AI, can help validation teams reduce redundant work and spend more time on patient-centric issues.

  3. CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture 9/2/2026

    Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.

  4. A Late-Stage QTPP, CQA, And CPP Mapping Guide 9/2/2026

    Clear connections among QTPP requirements, CQAs, and CPPs help teams preserve process knowledge. Examine how a structured mapping approach supports stronger risk assessments and documentation.

  5. Preparing Global Parenteral Sites For Annex 1 Compliance 9/1/2026

    Modern sterile manufacturing requires proactive quality risk management. Robust contamination control across facilities, processes, and supply chains supports compliance and patient safety.

  6. Controls For Retrieval-Augmented Generation In GxP 9/1/2026

    Validation teams deal with inherent variability all the time. The same principles for GMP — think visual inspection — can apply to probabilistic AI systems.

  7. FDA Issues New Guidance On Therapeutic Equivalence 9/1/2026

    The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?

  8. Aseptic Bag Filling: Meeting Annex 1 Without Compromise, Aseptic Filling Technologies That Ensure GMP Compliance And Product Success 8/29/2026

    Learn how specialized aseptic bag filling technologies maintain uncompromised process reliability and full regulatory compliance.

  9. Implementing AI Solutions In GMP While Managing Risk 8/28/2026

    When using artificial intelligence in GMP settings, risk management extends far beyond  validation. This discussion explores moving AI solutions out of the pilot phase.

  10. Implementing And Optimizing Your eQMS 8/25/2026

    This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.