Validation, Commissioning & Design Featured Articles

  1. Managing The Challenges Of Controlled Substance Manufacturing 9/22/2026

    How can manufacturers balance security, compliance, and supply continuity in controlled substance development and production?

  2. Vertex On Building Risk Into Manufacturing Network Strategy 9/17/2026

    Supply disruptions are becoming harder to predict. Explore practical strategies for continuity planning, supplier risk management, and network design to build lasting resilience.

  3. GMP Compliance In Pharmaceutical Manufacturing: Why Product Inspection Matters 9/17/2026

    Learn how integrating advanced inspection technology—including X-ray systems, metal detectors, and checkweighers—can optimize your compliance strategy and protect product quality.

  4. You Can't CAPA What You Can't Classify 9/16/2026

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

  5. Why CMC Continuity Is The Missing Link Between Development And Manufacturing 9/10/2026

    Discover why CMC continuity is the missing link between development and manufacturing, and how preserving connected product and process knowledge helps reduce handoff risk, accelerate tech transfer, and strengthen manufacturing readiness.

  6. The Growing Strategic Importance Of U.S. Pharmaceutical Manufacturing 9/4/2026

    Pharma manufacturing strategy now extends beyond cost and capacity, with resilience, flexibility, alignment, and market proximity supporting lasting success.

  7. 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.

  8. How Connected Bioanalytical Context Management Strengthens Bioanalytical Decision-Making 9/4/2026

    Preserving data context across bioanalytical workflows improves decision-making, ensures complete traceability, speeds up study review cycles, and prepares datasets for advanced AI.

  9. 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.

  10. Scaling Down For Success: Optimizing Single-Use Virus Filtration For Small-Scale Bioprocessing 9/2/2026

    Automation can bring greater consistency, product recovery, data capture, and operational efficiency to small-scale viral filtration once processes are sufficiently defined, helping gene therapy developers transition beyond highly manual workflows.