A company based in Switzerland
DIGITAL GMP. BUILT FROM EXPERIENCE.
Built for GMP.
Designed for people.
Documents, training and tasks in one clear system. Designed around GMP and ALCOA+ principles, with intuitive workflows and straightforward operation.
For pharmaceutical SMEs and manufacturing pharmacies.
CORE / DMS / TRAININGCONNECTED FROM THE START
GMP experience that works in practice.01 — 03
A LOOK INSIDE REGULATRACE
Your tasks.
Your documents. In view.
Access training tasks, records and documents from one central starting point. The overview shows what needs attention and where to continue.
WHAT MATTERS EVERY DAY
Keep the overview.
Know how to move forward.
A digital system should make daily work easier. That is the principle behind RegulaTrace.
THE AIM: MAKE GOOD WORK SIMPLE
GMP at its core.
Clarity every day.
Thoughtful development should handle the complexity. Your team needs clear steps, visible tasks and an interface that makes sense.
Made for GMP & ALCOA+
GMP and data integrity requirements shape development: controlled versions, defined permissions and traceable changes.
Easy to understand.
Clear language and understandable workflows help people see what needs doing and what comes next.
Intuitive to use.
Direct access to tasks, documents and training. Designed for straightforward navigation and simple operation, even under time pressure.
Evidence built into the approach.
Structured requirements and validation documentation provide a foundation for assessing your intended use.
SWISS COMPANY. CLEAR ACCOUNTABILITY.
Swiss company.
Clear accountability.
RegulaTrace is developed by Schmidt GMP-Consulting, a company based in Switzerland. The hosting provider and data locations for product operation have not yet been selected.
Data protection and security from the start.
Defined roles and permissions, traceable changes and controlled workflows are part of the development approach, making access and responsibility clear within the system.
For contact and newsletter data collected through this website, see our privacy notice.
ONE CORE. MORE POSSIBILITIES.
RegulaTrace keeps growing.
On the same foundation.
RegulaTrace is being expanded continuously through controlled releases. Following Core, DMS and Training, planned extensions include a deviation and CAPA module and a digital equipment list for the Validation Master Plan (VMP), built on the same core.
The aim is to bring documents, training and further quality processes together in one connected system, step by step.
DMSInitial scope
TrainingInitial scope
RegulaTrace CoreRoles · Permissions · Audit trail · History
Deviations & CAPAPlanned extension
VMP equipment listPlanned extension
Development roadmap, not an availability commitment. Scope and release dates will follow as development progresses.
CLEAR PACKAGE. CLEAR PRICING.
Everything you need.
Without unnecessary extras.
Core, DMS and Training in one package. A focused solution for everyday GMP work, without bloated feature lists.
One package. Predictable costs.
- No in-app purchases
- No hidden costs
- Monthly or annual payment
- Clear scope and price before you sign
This is the planned pricing model. Prices, included users and terms will be published before launch.
30+YEARS OF GMP EXPERIENCE
DEVELOPED BY CHRISTIAN SCHMIDT
From the laboratory.
From QA. From audits.
I know GMP from daily operations and from auditing quality systems. RegulaTrace brings these perspectives together: clear workflows for the people who use them every day.
Christian Schmidt · Schmidt GMP-ConsultingBE THERE EARLY
Be one of
the first five.
We are planning a special introductory offer for the first five companies to choose RegulaTrace and sign a contract at launch.
You can register your interest now. We will explain the benefits and terms before you make any commitment.
Non-binding. Registering is not a purchase and does not guarantee a place. Allocation and terms will be announced before the offer opens.
RegulaTrace is in development. This page presents the product approach. Verification, availability and release information will reflect the relevant product version. Validation for the intended use remains part of implementation at the user organisation.