the eQMS built for the responsible person
electronic quality management for swiss pharma wholesale · in pilot
The challenge
a role with high stakes and thin tools
In Swiss pharmaceutical wholesale, the Responsible Person (FvP) is personally accountable for every supplier qualified, every batch released and every regulatory change tracked under HMG and AMBV. Yet most of this work still runs on spreadsheets, PDF checklists, email threads and knowledge held in a few people’s heads. As portfolios and regulations grow, that quietly becomes the weakest link.
Sound familiar?
where the day goes
supplier & customer checks
Hours each month verifying authorisations across separate official registers — by hand, one partner at a time.
goods receipt on paper
An incoming-goods process spread across paper checklists and disconnected files, hard to reconstruct later.
regulatory change
No quick answer to the question that matters: “which of our SOPs does this new regulation affect?”
inspection pressure
Audit-readiness that depends on someone rebuilding the evidence trail under time pressure.
knowledge that walks out
Critical know-how that leaves the building when an experienced colleague does.
The eQMS
one system for the whole obligation
We’re building an electronic quality management system (eQMS) purpose-built for Swiss pharmaceutical wholesale — one place where supplier qualification, goods receipt, controlled documentation and regulatory monitoring finally live together, audit-ready by default.
Routine register checks run on their own, documents stay versioned and signed, and relevant legal changes surface automatically — already mapped to the SOPs they affect. Built on GDP and GAMP5 principles and running a local AI model, so sensitive data never leaves your own infrastructure. The Responsible Person still makes every decision — the eQMS just makes sure nothing slips and everything stays traceable.
Early access
curious?
The eQMS is currently running in a first pilot. If the challenges above feel familiar, we’d be glad to show you what we’re building — and to hear how you’d want it to work. info@imunaris.com