Guides/Platform Overview

Getting Started47:08

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.

Watch on YouTube

This is the big-picture tour of MoniDoseQMS — how the platform is put together and how the pieces connect. If you only watch one video, start here, then dive into the focused guides for each module.

What the overview covers

1
Build your QMS
Register, pick your industry and target markets, and assemble your quality system from only the modules you need — no implementation fee.
2
The platform day to day
Your dashboard, tasks, events, notifications, and the everyday tools that keep quality work organised.
3
Quality workflows end to end
Document control and e-signatures, change control, deviations and CAPA, risk management, design control, and more — all connected and traceable.
4
Compliance built in
ISO 13485, EU MDR, FDA QMSR, 21 CFR Part 11, and the EU AI Act, with audit-ready records and a tamper-evident audit trail throughout.

See all modules See pricing & plans Book a demo

Back to all guides

More guides

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.

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.