---
description: Review of Indelio Software: system overview, features, price and cost information. Get free demos and compare to similar programs.
image: https://gdm-localsites-assets-gfprod.imgix.net/images/software_advice/og_logo-55146305bbe7b450bea05c18e9be9c9a.png
title: Indelio | Reviews, Pricing & Demos - SoftwareAdvice GB
---

Breadcrumb: [Home](/) > [Quality Management Software](/directory/420/quality-management-software/software) > [Indelio](/software/561187/Indelio)

# Indelio

Canonical: https://www.softwareadvice.co.uk/software/561187/Indelio

> Indelio is the AI-native electronic quality management system (eQMS) built specifically for small medical device, diagnostics, biotech, and SaMD teams — the companies that need real 21 CFR Part 11, ISO 13485, FDA QMSR, and GAMP 5 rigor from day one, but are too small for Veeva or MasterControl.

Everything a device team needs is in one platform, with no tier-climbing to reach the modules that matter:

- Controlled Document Management — draft, review, approve, e-sign, version, and obsolete SOPs across a full lifecycle
- Design Controls \& Design History File (DHF) — inputs to outputs with a live traceability matrix, verification \& validation, and e-signed design reviews
- CAPA — root cause, corrective and preventive actions, effectiveness checks, QA-gated closure
- Customer Complaints with built-in MDR reportability (21 CFR 803)
- Corrections \& Removals / FSCA — health hazard evaluation, recall classification, 21 CFR 806
- Risk Management (ISO 14971)
- Change Control, Nonconformance, Internal \& Supplier Audits, Training, Supplier Qualification, Management Review, and Quality Policy \& Objectives

The compliance backbone is enforced in the database, not bolted on: an append-only, hash-chained, tamper-evident audit trail; two-component 21 CFR Part 11 electronic signatures re-verified at the moment of signing; and segregation of duties enforced server-side — so controls hold even against an administrator.

Go live in days, not a six-month rollout. Every plan includes a validation package (Validation Plan, System Requirements Specification, Part 11 traceability, IQ/PQ protocols, and automated OQ evidence) plus hands-on onboarding, with an independent validation consultant to qualify your instance and support your Performance Qualification (PQ).

AI, always human-in-the-loop: it drafts SOPs, redlines documents against the current regulations, and surfaces possible MDR-reportable complaints at intake — but a person always signs. AI is advisory, never the approver; nothing takes effect without a human electronic signature.

Right-sized, everything included, and transparently priced — no "contact sales to see a price." Ideal for startups navigating 510(k), De Novo, or PMA who need an audit-ready quality system without enterprise complexity or cost.
> 
> Verdict: Rated \*\*\*\* by 0 users. Top-rated for **Overall Quality**.

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## About the vendor

- **Company**: Indelio

## Commercial Context

- **Starting Price**: US$15,000.00
- **Pricing model**: Flat Rate (Free Trial)
- **Target Audience**: Self Employed, 2–10, 11–50
- **Deployment & Platforms**: Cloud, SaaS, Web-based
- **Supported Languages**: English
- **Available Countries**: Canada, United States

## Features

- AI Copilot
- Access Controls/Permissions
- Activity Dashboard
- Alerts/Notifications
- Approval Process Control
- Audit Management
- Change Management
- Complaint Management
- Compliance Management
- Corrective and Preventive Actions (CAPA)
- Data Import/Export
- Document Coding & Control
- Document Management
- Electronic Signature
- Generative AI
- ISO Standards Management
- Nonconformance Tracking
- Policy Management
- Reporting & Statistics
- Risk Assessment

## Support Options

- Email/Help Desk
- Knowledge Base

## Category

- [Quality Management Software](https://www.softwareadvice.co.uk/directory/420/quality-management-software/software)

## Links

- [View on SoftwareAdvice](https://www.softwareadvice.co.uk/software/561187/Indelio)

## This page is available in the following languages

| Locale | URL |
| en | <https://www.softwareadvice.com/product/561187-Indelio/> |
| en-AU | <https://www.softwareadvice.com.au/software/561187/Indelio> |
| en-GB | <https://www.softwareadvice.co.uk/software/561187/Indelio> |
| en-IE | <https://www.softwareadvice.ie/software/561187/Indelio> |
| en-NZ | <https://www.softwareadvice.co.nz/software/561187/Indelio> |

-----

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