GUEST COLUMNISTS

• Your 7 Decisions To Make Before MES Configuration

  Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.

• DEA Reveals Hidden Costs Of Analytical Validation Guidelines

  By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

• Qualification And Validation Of Depyrogenation Tunnels And Autoclaves

  Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization. 

• FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters

  The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

• You Can't CAPA What You Can't Classify

  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.

• 6 Modeling Approaches That Make Complex Bioprocess Data Useful

  AI algorithms can reduce data dimensionality more faithfully by interpreting multivariate features relevant to prediction or control.

• Building Trust In AI For Computerized System Validation

  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.