This site is now the public home for my professional profile, selected work, and writing around pharmaceutical validation.
The goal is simple: when people search for Niall O'Rourke, CSV, Part 11, validation, or AI in Pharma, there is a clear source that reflects my public work.
What it covers
- CSV and CQV experience
- Practical Part 11 and Annex 11 thinking
- AI in Pharma proof-of-concept tools
- Public projects, resources, and announcements
I will keep this space focused on useful posts rather than high-volume posting.