App comparison

Add up to 4 apps below to see how they compare. You can also use the "Compare" buttons while browsing.

GetApp offers objective, independent research and verified user reviews. We may earn a referral fee when you visit a vendor through our links. 

Qualio Logo

Life science quality software for start-ups and scale-ups

Last updated: October 2024

visit website

Table of Contents

Qualio - 2025 Pricing, Features, Reviews & Alternatives

What is Qualio?

Qualio is a cloud-based quality management software system designed for growing life science start-ups and scale-ups.

Qualio empowers medical device, pharmaceutical, biotech and contract organizations to get to market faster, boost revenue and cut risk. Over 650 companies in 80 countries trust Qualio to embed and automate unshakeable compliance with the demands of GxP, the FDA, ISO standards and more. Qualio unites your teams, processes and data in a single source of truth that supports a culture of quality and makes your business stronger, fitter and more competitive.

Benefits of using Qualio

- Built for medical device, pharmaceutical, biotech and contract research/manufacturing organizations

- Designed for start-ups and scale-ups who need to optimize their quality maturity

- Manage quality documentation, training, CAPAs, deviations, change control, suppliers, medical device design controls and more

- Voted the #1 easiest eQMS to set up and use

- The only eQMS with in-app document editing for total control of your document lifecycle

- Connect your entire business to a single source of quality trust backed by powerful analytics and full audit traceability

- Stay compliant with real-time and detailed insights into documents, people and actions. Monitor content sent for review, approval and training. Track change controls in progress and completed training.

- Create your own templates for documents, forms and records - or access pre-built industry-ready Qualio+ templates for accelerated compliance

- Used by over 650 companies to comply with:
- ISO 9001
- ISO 13485
- ISO 14971
- GxP, from GCP to cGMP and GDocP
- The EU MDR/IVDR
- UK Medical Devices Regulations
- ICH Qx guidelines

And more!

Starting from

ic-pricetag

No pricing info

view pricing plans
book a demo

Qualio's key features

GetApp's analysis of 43 verified user reviews collected between January 2022 and May 2024 identified Qualio's most critical features and how it performs according to users.

Document Management

Reviewers appreciate Qualio's document management capabilities. They highlight the ease of document traceability, retrieval, and the ability to link related documents. Users report that Qualio helps maintain compliance with ISO and GMP standards. They find the online review process with comments and suggestions valuable. However, some users mention weak control over draft creation. They also appreciate the clear audit trail and version control, which are essential for regulatory requirements. Of the 19 Qualio users who gave detailed accounts of their use of Document Management, 100% rated this feature as important or highly important.


Access Controls/Permissions

Users report that Qualio's access controls and permissions are valuable for managing user roles and access levels. They indicate that different user types have specific permissions, with admins having unlimited access. Reviewers appreciate the ability to control sensitive material and ensure compliance with regulations. They find it helpful to assign and remove users, although some suggest additional steps for draft creation and more access levels between normal and quality users. Of the 20 Qualio users who gave detailed accounts of their use of Access Controls/Permissions, 100% rated this feature as important or highly important.


Corrective and Preventive Actions (CAPA)

Reviewers highlight Qualio's CAPA capabilities as essential for compliance and product development. They appreciate the ability to create, monitor, and close CAPA actions using the Event tracker. Users report that CAPA management is easier with real-time tracking, task allocation, and customizable templates. They find it beneficial for linking CAPAs to relevant documents and ensuring accountability. Some users mention that it can be complicated but overall, it helps in maintaining regulatory compliance. Of the 21 Qualio users who gave detailed accounts of their use of Corrective and Preventive Actions (CAPA), 95% rated this feature as important or highly important.


Document Storage

Users find Qualio's document storage capabilities helpful for organizing and accessing documents. They appreciate the ability to store large volumes of documents securely in the cloud. Reviewers report that Qualio ensures compliance with ISO 13485 and FDA regulations. They highlight the ease of accessing document history and maintaining product-related information. Users also mention that Qualio helps reduce paper usage and keeps documents organized in one place, making it ideal for document storage. Of the 20 Qualio users who gave detailed accounts of their use of Document Storage, 90% rated this feature as important or highly important.


All Qualio features

Features rating:

Monitoring
Real-Time Reporting
Environmental Compliance
Risk Analysis
Document Review
Risk Management
Document Coding & Control
Data Visualization
Single Sign On
User Management
Version Control
Workflow Management
Assessment Management
Electronic Signature
Archiving & Retention
Change Management
Secure Data Storage
Compliance Tracking
Audit Trail
Incident Management
Quality Control
ISO Standards Management
Compliance Management
FDA Compliance
Customizable Reports
Content Management
ISO Compliance
Collaboration Tools
Training Management
Defect Tracking
Risk Assessment
Audit Management
Equipment Management
Communications Management
Complaint Management
Issue Management
Audit Planning
Maintenance Management
Real-Time Data
Real-Time Notifications
Real-Time Analytics
Real-Time Updates
Activity Dashboard
Reminders
Reporting & Statistics
Revision History
Trend Analysis
Training Administration
Third-Party Integrations
Role-Based Permissions
Root Cause Analysis
Rules-Based Workflow
Search/Filter
Status Tracking
Supplier Management
Supplier Quality Control
Tagging
Task Management
Activity Tracking
Alerts/Escalation
Alerts/Notifications
API
Approval Process Control
Approval Workflow
Change Planning
Commenting/Notes
Configurable Workflow
Course Management
Customizable Branding
Customizable Forms
Customizable Templates
Dashboard
Data Import/Export
Document Automation
Document Capture
Document Generation
Document Lifecycle Management
Document Templates
Drag & Drop
Email Alerts
File Management
Forms Management
Full Text Search
Governance
HIPAA Compliant
Inspection Management
Nonconformance Tracking
Policy Management

Qualio awards

Qualio alternatives

Qualio logo
4.6
(124)
visit website

Starting from

ic-pricetag

No pricing info

Free trial
Free version
Ease of Use
Features
Value for Money
Customer Support
MasterControl Quality Excellence logo
4.5
(432)
visit website

Starting from

25000

Per year

Free trial
Free version
Ease of Use
Features
Value for Money
Customer Support
HSI Donesafe logo
4.7
(81)
visit website

Starting from

ic-pricetag

No pricing info

Free trial
Free version
Ease of Use
Features
Value for Money
Customer Support
Autodesk Construction Cloud logo
4.3
(2.1K)
visit website

Starting from

ic-pricetag

No pricing info

Free trial
Free version
Ease of Use
Features
Value for Money
Customer Support

Qualio pricing

Value for money rating:

Starting from

ic-pricetag

No pricing info

Pricing details
Subscription
Free trial
Free plan
Pricing range
view pricing plans

Qualio integrations (10)

Integrations rated by users

We looked through 124 user reviews, to identify which products are mentioned as Qualio integrations, and what is the users perception.

Benchling logo
Benchling

Integration rating: 5.0 (1)

Benchling is the location of all our research lab notebook entries and manufacturing BPDs

JJ

Janelle Johnson

Biomanufacturing Lead

Integration rating: 5.0 (1)

Jira logo
Jira

Integration rating: 3.0 (1)

Qualio support options

Typical customers

Freelancers
Small businesses
Mid size businesses
Large enterprises

Platforms supported

Web
Android
iPhone/iPad

Support options

Email/Help Desk
Chat
Knowledge Base
Phone Support
FAQs/Forum
24/7 (Live rep)

Training options

Live Online
Videos
Documentation
Webinars

Qualio reviews

Overall rating

4.6

/5

124

Positive reviews

93

%

Rating breakdown
  • Value for money
  • Ease of use
  • Features
  • Customer support
  • Likelihood to recommend8.57/10
Rating distribution

5

4

3

2

1

79

36

8

1

0

Pros
The Customer Service both supporting the induction of the platform and the every day query customer service is outstanding and could not compliment them more.
Easy to use with a very intuitive user interface, compliance with CFR 21 part 11, outstanding customer support, swift document navigation.
Aesthetically pleasing, Ease of use, ease of support, at a competitive cost. Qualio meets all expectations.
Cons
Most software will encounter an error now and then. While it is infrequent with Qualio, the error messages can be vague, prompting support calls that could be avoided with better detail.
I did not find anything that i dislike in Qualio.
Missing a project specific documents training tracker / training sign-off module.

Qualio FAQs

Q. What type of pricing plans does Qualio offer?

Qualio has the following pricing plans:
Pricing model: Subscription, Open Source


Q. Who are the typical users of Qualio?

Qualio has the following typical customers:
Mid Size Business, Small Business


Q. What languages does Qualio support?

Qualio supports the following languages:
English


Q. Does Qualio offer an API?

Yes, Qualio has an API available for use.


Q. What other apps does Qualio integrate with?

Qualio integrates with the following applications:
Jira, Xray, Okta, ComplianceWire, Confluence, Azure DevOps Services, Asana, TestRail


Q. What level of support does Qualio offer?

Qualio offers the following support options:
Email/Help Desk, Chat, Knowledge Base, Phone Support, FAQs/Forum, 24/7 (Live rep)

Related categories