GUEST COLUMNISTS

• 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.

• July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing

  Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

• In Bioprocessing, Trusted Data Is A Process Variable

  As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.

• Are Biopharma Companies Outsourcing Their Ability To Think?

  Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.

• Why Operational Readiness Is The Missing Piece In Biosimilar Adoption

  Biosimilar success depends on seamless execution. Strong care coordination, patient education, and operational readiness are essential to improve access, adherence, and outcomes.

• Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring

  Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

• Exploring Takeda's Template For Sustainable Steam Generation

  Takeda designed a model for delivering steam at 11 bar and up to 184 degrees using natural refrigerant and waste heat at one of its largest production sites.