Industry Perspectives
-
Closing The MES Value Gap: Why Technology Isn't The Problem
5/14/2026
Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.
-
Why Your MES RFP Is Failing Before It Starts
5/6/2026
Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.
-
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.
-
MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
2/20/2026
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.
-
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 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
1/21/2026
The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.
-
Why Use Total Organic Carbon Analysis For Cleaning Validation?
1/21/2026
Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.
-
Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards
10/14/2025
This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.
-
Trust But Verify: Validating AI In Pharma's GxP World
10/3/2025
Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.
-
Considerations For Rapid Prototyping In Medical Device Development
9/15/2025
Rapid prototyping has taken the medical device industry by storm, but there are pros and cons that device developers need to consider.