Guides/Build your own QMS

Getting Started3:31

Build your own QMS

Register an account and assemble your quality system from only the modules you need — set up in minutes, with no implementation fee.

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Getting started with MoniDoseQMS takes a few minutes — and you build the system around exactly what you need. There's no implementation fee and nothing to install.

What you'll do

1
Create your account
Enter your company information and your own details. You're set up in minutes — no implementation fee, nothing to install.
2
Start free for 14 days
Begin on the free trial, then choose the plan — Foundation, Growth, or Enterprise — that grows with what you select.
3
Tell us your industry
Pick your industry and MoniDoseQMS recommends the modules that fit, so you know what to choose even if you're new to this.
4
Choose your target markets
Full support today for EU MDR, FDA, and the UK. Canada, Japan, Australia, Switzerland, Brazil, China, and South Korea are on the roadmap.
5
Pick only the categories you need
Each category is a set of modules. Document Control & Quality, for example, includes the Document Management Hub, electronic signatures, an SOP & ISO template library, change control, CAPA, preventive actions, and record archival.
6
Add premium options (optional)
Extra storage, SSO with Azure AD or Google Workspace, API access, priority support, and automated backups with disaster recovery.
7
You're ready
No configuration headaches and no big upfront fee. If you have a partner code, you may qualify for additional free usage or a discount.

Why it's different

Many platforms sell you a package full of things you'll never use — and you pay for all of it. MoniDoseQMS is modular: you enable and pay for only what you need, so it stays efficient and affordable, especially for startups.

See pricing & plans Book a demo

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More guides

Platform tour

A guided tour of MoniDoseQMS after you log in — your profile, the everyday tools (notifications, recycle bin, tasks, events, regulatory news), and the dashboard.

Document Management Hub

A deep dive into the Document Management Hub — create controlled documents, link them across modules, route them through review and approval, sign with 21 CFR Part 11 e-signatures, and archive records for the long term, all inside MoniDoseQMS.

Change Control

Walk through MoniDoseQMS's change control module — create change requests, set priority and type, link to any QMS module, run impact assessments, attach documents, and manage the full review and approval workflow.

Deviations, CAPA & Preventive Actions

Walk through deviations, non-conformance reports, CAPA management, preventive actions, notes, and the records archive — the full corrective-and-preventive workflow inside MoniDoseQMS.

Risk Management

Walk through MoniDoseQMS's risk management module — create risk assessments based on ISO 14971, score probability and severity, apply control measures, and track residual risk with full traceability.

Design & Development

Walk through design projects and the full design control lifecycle in MoniDoseQMS — from design input and output to verification, validation, transfer, change control, and labeling, all aligned with FDA 21 CFR 820.30, EU MDR, ISO 13485, and IEC 62304.

SOP & ISO Template Library

Browse the built-in SOP and ISO template library in MoniDoseQMS — start from hundreds of pre-written, standards-aligned templates instead of a blank page, then customise and route them through document control.

Platform Overview

A complete walkthrough of MoniDoseQMS — see how the whole platform fits together, from building your quality system to running day-to-day quality work across all 13 categories.