AI in the Age of Regulated Work with ALCOA+ Principles
TL;DR
What changes with AI: You now create records at three points: training data, prompts, and outputs. Treat each as controlled.
...
CSV vs CSA in 2025: What Changes and What Doesn’t
Computer software assurance is the FDA’s risk-based way to build confidence in software that supports production and quality activities...
Metrics that Matter in Validation Lifecycle Management
Validation lifecycle management is not a one-off task. It is the system that plans, builds, tests, releases, and maintains GxP changes ...
Data Migration Validation for Regulated Systems
CSV data migration is the controlled process of moving regulated records between systems and proving, with evidence, that the records k...