01About
Twenty yearsof projects.
Who I am, what I do, and how I work.
My name is Benjamin de Bruijne. I live in Belgium, near Brussels, and I have worked in IT for over twenty years — over 200 web projects built or delivered: development, project management, product, quality, digital transformation.
I have led projects in highly regulated environments, including several years in the biopharmaceutical industry as an AI & GxP Solutions Architect: computer system validation (CSV), GxP and 21 CFR Part 11 compliance, data integrity, IT/OT integration and document governance. In parallel, I built my own products: Service-Volée, Pulse Noir and BiblioPulse (a 2,150-reader crime-fiction community and its library), and an ecosystem around control of data: Beneloo (SME visibility in AI engines), the Observatory (the measurement, sector by sector) and Singulr, the non-profit I chair, which operates sovereign digital commons including a Git forge hosted in Belgium.
That double track is my edge: the rigour of regulated environments, the speed of a freelancer. I can scope, document and deliver by the book, and I can also code a complete tool in a few days when that is what is needed.
I work through my company, Hakuna Matata SRL, and I pick tools that leave you in control: code you own, data at home, no opaque subscriptions.
See the Deliver offer: IT projects in regulated environments →
At a glance
- Current role
- AI & GxP Solutions Architect, biopharmaceutical group (UCB)
- Base
- Rhode-Saint-Genèse, Belgium
- Languages
- French, English, Dutch
- Company
- Hakuna Matata SRL
- Stack
- Astro, React, Next.js, Node, PHP, Postgres, Supabase, AI (OpenAI, Claude)
02Frequently asked questions
What is GxP compliance?
GxP compliance means following the regulatory good practices of the pharmaceutical, biotechnology and medical device industries: GMP (manufacturing), GLP (laboratory), GCP (clinical), GDP (distribution). For IT systems, it implies validated systems, data integrity and documentation proving, at any time, that the process is under control.
What is CSV (Computer System Validation)?
CSV is the documented process that demonstrates a computerised system does exactly what it is meant to do, consistently and reproducibly. It covers user requirements, risk analysis, qualification testing (IQ, OQ, PQ) and change management. It is a regulatory requirement in the pharmaceutical and biopharmaceutical industries to guarantee data integrity.
Do you only work with biopharmaceutical companies?
No. My deepest expertise is in biopharma and GxP compliance, but I also work with SMEs, freelancers, non-profits and clubs on their websites, automations and AI projects. What does not change from one sector to the next: the method, the documentation and a tool that runs.