Featured Pharma Online Editorial

  1. 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.

  2. 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.

  3. AI Needs Human Oversight To Better GMP Documentation 8/12/2026

    In a Pharmaceutical Online Live discussion on building inspection-ready systems with digital documentation, panelists emphasized that AI can accelerate review, trend analysis, and inspection response, but only when governed, validated, and kept firmly under human quality oversight.

  4. Building AI Readiness Through Cross Collaboration 7/22/2026

    AbbVie’s Operations Quality Assurance Innovation Accelerator offers a practical model for moving from AI enthusiasm to governed, people-centered execution.

  5. Bayer Adds A Spine To Modularity For Scale Without Disruption 7/16/2026

    Modular facility concepts offer a different path, giving manufacturers the ability to expand capacity stepwise, standardize core infrastructure, and adapt production environments as product portfolios evolve

  6. 7 Facilities Pilot PreCheck for Faster Approval 7/13/2026

    A more streamlined path to operational new pharmaceutical facilities in the U.S. may be on the horizon. Nearly a year after the PreCheck Pilot Program was introduced by the U.S. Food and Drug Administration (FDA) in August 2025, the first seven participating facilities have been announced.

  7. Transforming Computer System Validation In The Life Sciences Industry 7/10/2026

    Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.

  8. Inside Chugai's Digital Infrastructure Strategy 6/29/2026

    When a facility is fully automated and designed for manufacturing flexibility, it needs a digital infrastructure that pulls the systems together, reports data accurately and efficiently, and recognizes areas for continuous improvement.

  9. [VIDEO] GLP-1 Manufacturing's New Bottlenecks At Multi-Ton Scale 6/24/2026

    “At multi-ton scale, the challenge becomes less about making the molecule and more about controlling the variability of the process in this interconnected system,” explained Villain.

  10. Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed? 6/23/2026

    The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence.