ARTICLES BY JON O'CONNELL

• 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.

• 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.

• Implementing AI Solutions In GMP While Managing Risk

  8/28/2026

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

• What Biopharma Often Overlooks In A Scheduled Shutdown

  6/26/2026

  Shutting down an operating biologics facility upsets systems often designed for continuous operation. One expert shares his tips for preventing unnecessary problems.

• Is Your AI Model Trustworthy And Credible In GMP Processes?

  6/17/2026

  Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.

• What Reliance, Annex 1, And AI Mean For The Future Of GMP

  5/29/2026

  EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity.

• A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight

  5/18/2026

  A Takeda quality executive demonstrates how a team of AI agents uses synthetic data to provide decision support ahead of CDMO audits.

• The Stepwise Path Lilly Mapped From Paper To Digital Logbooks

  4/30/2026

  Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

• Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network

  4/17/2026

  Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.

• A Peek Into Novo Nordisk's Sustainable Facility Construction Mindset

  2/18/2026

  Fill/finish operations are famously resource-heavy. Nonetheless, Novo set out to achieve ambitious environmental goals with its $4.1 billion project in North Carolina.

• New ISPE Framework Targets Uncertainty In Pharma's AI Deployment

  1/29/2026

  International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

• The Module Type Package Wants All Your Equipment To Start Talking

  12/11/2025

  A forthcoming ISPE guide uses case studies to aid in the design of plug-and-play process skids with implications for every step in the manufacturing process continuum.

• Lessons In Quality From Sanofi's Plai.qa

  11/24/2025

  The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.

• Here's What You Need To Know About The Access Consortium Pathway

  11/20/2025

  Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.

• The Transition To E-Labeling Is More Than Uploading PDFs

  10/31/2025

  Despite tight restrictions, patchwork regulations, and an unclear timeline, one researcher says we're heading toward fully-digitalized drug labels.