
About Qualio
Qualio is the easiest way for businesses in Healthcare & Life Sciences to manage Quality and Compliance.
Qualio automates the painful paperwork and processes required by regulators like the FDA for 2x faster accreditation and approval. It helps you work 5x faster than paper or traditional solutions to manage Document Control, Training, NCRs, CAPAs, Audits, Suppliers, Complaints and more.
Define workflows for approval and review. Create records with automated numbering and easy linking of related content. Capture approvals with digital signature and automatically notify users of approved documents. You can use Qualio to manage training with automated notifications, reminders and training lists. Ensure compliance with any regulatory body and generate comprehensive audit trails to further meet compliance.
All your data is securely stored and backed-up through Qualio. Using Qualio, you can reduce costs through streamlining time consuming workflows by 5x and lowering risk through automating the recording of key compliance information.
In addition, Qualio's simple and powerful reporting makes it easy to see what's happening in real-time. Utilize Qualio's partner network of experts to work with you through the software and provide you with the key knowledge you need. Qualio provides an intuitive interface and live support so you can get started immediately.
Pricing starting from:
Not provided by vendor
- Free Version
- Free Trial
- Subscription
Key benefits of Qualio
- Designed for Medical Devices, Biotech, Pharma, Digital health and CxOs (Manufacturing, Testing Laboratories, Research Orgs)
- Maintain 100% compliance and audit readiness at all times.
- Set up automatic email notifications to reviewers and approvers.
- Real-time parallel approval process. All reviewers can view the same document and previous versions can be compared against each other.
- Easily collaborate. You can add comments and mark documents as reviewed to immediately notify the author.
- Send automatic training notifications via email to your team at any time.
- 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.
- Everything is fully customizable. Create your own templates for documents, forms and records. You can even specify document numbering and approval processes.
Designed to help you comply with important quality standards Including:
- Quality management systems (ISO 9001)
- Medical Devices (ISO 13485)
- FDA Quality Systems Regulations (QSR)
- e-record keeping (FDA 21 CFR p11, Annex 11)
Typical Customers
- Freelancers
- Small Businesses (2-50)
- Mid-size Companies (51-500)
- Large enterprises (500 and more)
Deployment
- Cloud-based
- On-premise
Markets
Australia, Canada, Germany, Denmark, Finland , France, United Kingdom, Indonesia, Ireland, Israel, Italy, Japan, South Korea, Netherlands, Norway, New Zealand, Sweden, Taiwan, United States, South Africa and 15 others
Supported Languages
English
Pricing starting from:
Not provided by vendor
- Free Version
- Free Trial
- Subscription
Images






Features
Total features of Qualio: 68
Alternatives
MasterControl Quality Excellence

Documate

Digital Business Transformation Suite

Greenlight Guru

Reviews
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Software buyers need your help! Product reviews help the rest of us make great decisions.

- Industry: Information Technology & Services
- Company size: 2-10 Employees
- Used Weekly for 6-12 months
-
Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support Software
- Likelihood to recommend 10.0 /10
Great eQMS software
Reviewed on 8/10/2022
This software is a quick and effective method of managing quality procedures. The system keeps...
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.
- Industry: Biotechnology
- Company size: 11-50 Employees
- Used Weekly for 6-12 months
-
Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support Software
- Likelihood to recommend 9.0 /10
Great Software
Reviewed on 1/27/2022
It is very useful for anyone with or working towards ISO certification. Very audit friendly -...
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.
Response from Qualio
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.
- Industry: Biotechnology
- Company size: 11-50 Employees
- Used Daily for 2+ years
-
Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support Software
- Likelihood to recommend 5.0 /10
Needs basic improvements
Reviewed on 1/27/2022
Document Management works well
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 ControlReasons for Switching to Qualio
PriceResponse from Qualio
We appreciate your feedback regarding change control and periodic review reports and have provided this to our product team.
- Industry: Medical Devices
- Company size: 51-200 Employees
- Used Daily for 2+ years
-
Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support Software
- Likelihood to recommend 9.0 /10
Qualio as a regulated quality management system
Reviewed on 2/2/2022
Tech support is superior. They listen to suggestions and resolve problems quickly. I fully exercise...
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
Response from Qualio
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.
- Industry: Medical Devices
- Company size: 501-1,000 Employees
- Used Daily for 1+ year
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Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support Software
- Likelihood to recommend 9.0 /10
Excellent people supporting an excellent product
Reviewed on 2/1/2022
Our Design Control process is much tighter. Document Control requires less time and effort. We...
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.
Response from Qualio
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.
Qualio FAQs
Below are some frequently asked questions for Qualio.Q. What type of pricing plans does Qualio offer?
Qualio offers the following pricing plans:
- Starting from: View Pricing Plans
- Pricing model: Subscription
- Free Trial: Not Available
Please contact Qualio for pricing details.
Q. Who are the typical users of Qualio?
Qualio has the following typical customers:
Self Employed, 2-10, 11-50, 51-200, 201-500
Q. What languages does Qualio support?
Qualio supports the following languages:
English
Q. Does Qualio support mobile devices?
Qualio supports the following devices:
Q. What other apps does Qualio integrate with?
Qualio integrates with the following applications:
Asana, Azure DevOps Services, Confluence, Jira, Jira Work Management, Okta, TestRail
Q. What level of support does Qualio offer?
Qualio offers the following support options:
Email/Help Desk, FAQs/Forum, Knowledge Base Software, Phone Support, 24/7 (Live rep), Chat
Related categories
See all software categories found for Qualio.