Welcome to the NaevoLab Resources hub — a space for ideas, insights, and discoveries in validation and emerging technologies.
Articles & Insights
FDA Guidance (Draft) : CSA for production and Quality Systems Software
A key draft shaping the future of validation, shifting teams toward a risk-based, assurance-focused approach for production and quality software in regulated environments.
🔗 Draft
Curiosity Corner
Curated external reading — regulatory, technical, and conceptual.
Salesforce : State of Data and Analytics (2ndEdition)
A Salesforce report exploring the impact of AI acceleration on how organisations use and activate data, highlighting data and AI foundations as key challenges.
🔗 Report
IBM: What is an AI stack?
A clear breakdown of how AI systems are structured — showing how data, models, context, and infrastructure connect to power real-world AI. It also goes beyond the hype, covering fundamentals like machine learning, feature engineering, training, deep learning, and MLOps in a clean, no-noise way
Regulatory Perspectives for AI/ML Implementation in Pharmaceutical GMP Environments
An insightful paper on how AI/ML fits into pharmaceutical manufacturing, outlining key regulatory expectations, practical challenges, and major FDA AI/ML milestones from 2014–2025.