What Is Qualio?

Qualio is a cloud-based quality management software system designed for life science companies. Qualio empowers medical device, pharmaceutical, biotech and contract organizations to get to market faster, boost revenue and cut risk. Over 500 companies in 80 countries use Qualio to embed and automate GxP, FDA and ISO compliance. 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.

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.

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

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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 5 months ago

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 US
Verified LinkedIn User
Biotechnology, 11-50 Employees
Used the Software for: 6-12 months
Reviewer Source

Alternatives Considered:

Great Software

5.0 12 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.

Qualio Response

11 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 US
Biotechnology, 11-50 Employees
Used the Software for: 2+ years
Reviewer Source

Alternatives Considered:

Needs basic improvements

3.0 12 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.

Qualio Response

11 months ago

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

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

Qualio as a regulated quality management system

5.0 11 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

11 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.

jared
Director, Strategic Projects in US
Medical Devices, 501-1,000 Employees
Used the Software for: 1+ year
Reviewer Source

Excellent people supporting an excellent product

5.0 11 months ago

Comments: Our Design Control process is much tighter. Document Control requires less time and effort. We have elevated our Risk Management game. Our Quality people are happier using such a well integrated tool.

Pros:

Qualio is very well and highly integrated. There is a relatively short learning curve, then quite intuitive. The materials available for on-boarding and learning are very well done and thorough. The built-in chat function for fast support is excellent - so easy to use. The people of Qualio are high caliber and there is clearly a culture of Customer Service. There is a very good balance between structure and customization - Qualio has found the sweet-spot. The SOPs and templates offered as a starting point are well written and concise.

Cons:

I am hard-pressed to describe an aspect of the platform or the company that I would like to see changed. We do more than Medical Devices. We are in the process of considering how we might use Qualio outside of Medical and what would have to happen to accomplish such a goal - this is perhaps something Qualio might consider as an evolutionary initiative.

Qualio Response

11 months ago

Hi Jared, thank you for your fantastic review and we're so happy to hear that Qualio has made life easier for your Quality team! We'd love to get more of your thoughts on scaling usage of Qualio outside of Medical Device and your CS contact can answer any questions you might have on this.