The "Shadow System" Risk: A Regulatory Analysis of Spreadsheets in GxP
Analysis of spreadsheet risk in GxP environments through the lens of FDA warning letters, focusing on the gap between user intent and regulatory reality.
Insights
Case studies, technical articles, and analysis.
Reference Architectures
Standard blueprints for retiring high-risk spreadsheets and establishing a validated state.
Batch Release Spreadsheet Remediation
Reference architecture: The blueprint for converting a pharmaceutical lab's calculation spreadsheet into a validated, 21 CFR Part 11 compliant application.
Temperature Excursion Adjudication
Reference architecture: Remediating a cold chain monitoring spreadsheet into a validated system with automated file ingestion and real-time alerts.
Technical Articles
Deep technical analysis on regulatory compliance, validation methodology, enterprise architecture, and technology strategy for regulated systems.
The Deterministic Future: AI Strategy for Regulated Systems
Strategic analysis: Navigating the collision of Generative AI, GxP Compliance, and the EU AI Act. Learn how to implement AI safely in regulated systems with Build-Time AI strategies.
From Blind Spots to Board-Ready: Taming Local AI with an MCP Proxy
A technical deep dive into implementing secure Model Context Protocol proxies for enterprise AI systems. Learn how to control and manage local AI tools.
Enterprise AI 2.0: Building a Comprehensive AI Backbone
Discover Enterprise AI 2.0 in action. Learn about the comprehensive AI backbone that connects documents, data, and systems into a strategic asset organizations can actually manage.
Analysis
Strategic analysis and frameworks for understanding enterprise AI systems, architecture patterns, and technology governance.
EAIS: Taming the Chaos
Exploring the components and architecture of modern enterprise AI systems. Learn how to build secure, manageable, and powerful AI solutions with our structured 8-layer approach.