Featured Pharma Online Editorial

  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. AI Governance Is Just Like Driving A Race Car 9/1/2026

    Though some skeptics remain, nearly every business is at some stage of AI adoption. The technology has proven applications in pharmaceutical manufacturing, but effective governance must keep pace with its rapid development. That challenge is familiar to Bill Reid, healthcare and life sciences lead in Google’s Chief Information Security Office (CISO).

  5. 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.

  6. 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?

  7. 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.

  8. 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.

  9. A Much-Improved Approach For Understanding And Managing Safety Risks 8/18/2026

    Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

  10. CSV Assumes The AI System Sits Still — It Doesn't. 8/17/2026

    The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.