What Is Qualio?

Rated #1 easiest and fastest QMS, CAPA, and Compliance software by Medical Device, Pharma, and Biotech organisations.

Hundreds of FDA, ISO, and GxP regulated companies in over 80 countries trust Qualio to bring their quality team, tools, processes, and data together in one easy to manage place.

With industry experts on staff and customer service on call, we partner with you to implement strategy, prepare for audits, and convert manual processes to digital. Get a personalised demo today!

Who Uses Qualio?

Quality-centric start-up and scale-up life science companies hungry to grow, unlock new markets and beat their competition with a culture of quality.

Where can Qualio be deployed?

Cloud-based
On-premise

About the vendor

  • Qualio
  • Located in San Francisco, U.S.
  • Founded in 2010

Qualio support

  • Phone Support
  • 24/7 (Live rep)
  • Chat

Countries available

Australia, Canada, Denmark, Finland, France and 15 others

Languages

English

Qualio pricing

Starting Price:

Not provided by vendor
  • No free trial
  • No free version

Qualio does not have a free version and does not offer a free trial.

Pricing plans get a free trial

About the vendor

  • Qualio
  • Located in San Francisco, U.S.
  • Founded in 2010

Qualio support

  • Phone Support
  • 24/7 (Live rep)
  • Chat

Countries available

Australia, Canada, Denmark, Finland, France and 15 others

Languages

English

Qualio videos and images

Qualio Software - Automate document & record control
Qualio Software - Conquer your to-do list
Qualio Software - Effortlessly capture training
Qualio Software - Track everything with reports
Qualio Software - ISO 14971 Risk Configuration & Assessment
View 6 more
Qualio video
Qualio Software - Automate document & record control
Qualio Software - Conquer your to-do list
Qualio Software - Effortlessly capture training
Qualio Software - Track everything with reports
Qualio Software - ISO 14971 Risk Configuration & Assessment

Features of Qualio

  • Access Controls/Permissions
  • Archiving & Retention
  • Audit Management
  • Audit Planning
  • Change Management Software
  • Collaboration Tools
  • Communications Management
  • Complaint Management Software
  • Compliance Management
  • Compliance Tracking
  • Controls Audit
  • Corrective and Preventive Actions (CAPA)
  • Dashboard Software
  • Document Coding & Control
  • Document Storage
  • Equipment Management
  • Forms Management
  • Incident Management Software
  • Maintenance Management Software
  • Risk Assessment
  • Risk Management Software
  • Supplier Quality Control
  • Task Management Software
  • Training Management
  • Version Control

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WorkClout helps quality engineering teams improve quality and get product-to-market faster. Fully implement in just seven days.
Quality Management Software for FDA & ISO Compliance. QT9 QMS Includes 23+ Modules on a Cloud-Based Platform for Unlimited Scalability Learn more about QT9 QMS
ETQ is the world’s most comprehensive, flexible & proven QMS & EHS software for quality-centric organizations in dozens of industries. Learn more about ETQ Reliance
No user license fees 20+ Out of the box modules Extremely Configurable
FORM OpX improves operational compliance by digitizing audits and inspections on mobile to reduce risk and improve safety and quality. Learn more about FORM OpX
#1 all-in-one HSEQ platform to solve ALL your safety requirements. Simple for workers to use, simple for managers to customize. Try now Learn more about HSI Donesafe

Reviews of Qualio

Average score

Overall
4.7
Ease of Use
4.6
Customer Service
4.8
Features
4.3
Value for Money
4.6

Reviews by company size (employees)

  • <50
  • 51-200
  • 201-1,000
  • >1,001

Find reviews by score

5
70%
4
25%
3
5%
Atul Pratap
Atul Pratap
Sales And Marketing Specialist in India
Verified LinkedIn User
Information Technology & Services, 2-10 Employees
Used the Software for: 6-12 months
Reviewer Source

Great eQMS software

5.0 2 months ago New

Comments: This software is a quick and effective method of managing quality procedures. The system keeps track of everything. It is suitable for small businesses and is also scalable as they expand.

Pros:

This software has a relatively simple learning curve. The programme has a lot of flexibility and lets you format procedures and records anyway you choose. The software contains useful features, easy-to-use interface, and finding documents is not too difficult either. Tech support is also excellent.

Cons:

It's challenging to create documents with Qualio. The formatting options could be improved. Some areas lack audit trails.

Mickey
Mickey
Controller in U.S.
Verified LinkedIn User
Biotechnology, 11-50 Employees
Used the Software for: 6-12 months
Reviewer Source

Great Software

5.0 8 months ago

Comments: It is very useful for anyone with or working towards ISO certification. Very audit friendly - would recommend.

Pros:

It is extremely straight forward to use. You can train managers quickly on it and use/adoption rate is very high.

Cons:

It is a bit pricey. However it is more versatile and easier to use than most major software - worth the extra costs.

Alternatives Considered: Greenlight

Reasons for Switching to Qualio: Greenlight also seemed like a great product but the implementation speed and ease of Qualio was out deciding factor.

Qualio Response

8 months ago

Hi Mickey, thank you for your review and we're happy to hear that Qualio has made your audit processes simpler and easier to manage.

Irma
Director of Quality Assurance in U.S.
Biotechnology, 11-50 Employees
Used the Software for: 2+ years
Reviewer Source

Needs basic improvements

3.0 8 months ago

Comments: Document Management works well

Pros:

Training process works well. The system can generate reports for each employee.

Cons:

Change control and periodic review reports need improvement. I cannot generate proper reports that provide visibility of these processes. The change control report is less than acceptable. Please fix this. I have explained this in the past.

Alternatives Considered: Document Control

Reasons for Switching to Qualio: Price

Qualio Response

8 months ago

We appreciate your feedback regarding change control and periodic review reports and have provided this to our product team.

Santino
Student in Jamaica
Education Management, 501-1,000 Employees
Used the Software for: 6-12 months
Reviewer Source

Qualio Review

4.0 4 months ago

Pros:

Qualio is an awesome document manager especially for persons looking to transition from paper to electronic record keeping. This platform has an excellent user interface that is easy to navigate with practice. Excellent customer support from the team made implementation easier.

Cons:

No issues have been experienced with the platform so far.

Barbara
Sr Q Mgr in U.S.
Medical Devices, 51-200 Employees
Used the Software for: 2+ years
Reviewer Source

Qualio as a regulated quality management system

5.0 8 months ago

Comments: Tech support is superior. They listen to suggestions and resolve problems quickly. I fully exercise the flexibility of the software without having to worry about obsolescence. The help videos and FAQ's are excellent

Pros:

The software has flexibility in its use of configurable templates that allows custom formatting of procedures and records, although a basic set of templates is provided if customization is not needed. The audit trails are easily accessible and provide good detail. The Events module allows documenting actions that require staged approvals and tracking progress. Event types can be created and customized. The Dashboard is a quick view of all open tasks. Qualio is constantly improving and expanding their SW features.

Cons:

Training metrics are not customizable. There is not a suspended status for people on extended leave, such as for pregnancy. the arrangement to provide limited access to some records could be better designed

Qualio Response

7 months ago

Thank you for your thorough and excellent review, Barbara! We're happy to hear that our support team and customer resources have been helpful to you. Your feedback on training metrics and access customization has been relayed to our product team.