GUEST COLUMNISTS

• 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.

• A Gentler Cell Line Selection Method Using microRNA

  Traditional selection stresses surviving cells. New research shows how structurally interacting RNA may use endogenous microRNA for a faster, nontoxic selection process.

• Controls For Retrieval-Augmented Generation In GxP

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

• Implementing AI Solutions In GMP While Managing Risk

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

• Implementing And Optimizing Your eQMS

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

• A Much-Improved Approach For Understanding And Managing Safety Risks

  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.

• CSV Assumes The AI System Sits Still — It Doesn't.

  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.