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
Supported Languages
English
Pricing starting from:
Not provided by vendor
- Free Version
- Free Trial
- Subscription
Images
Features
Total features of Qualio: 90
Alternatives
Veeva QualityOne EQMS
Document Control
Greenlight Guru
QT9 QMS
Reviews
Already have Qualio?
Software buyers need your help! Product reviews help the rest of us make great decisions.
- 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 10.0 /10
The perfect system for startups and young organizations
Reviewed on 2019-01-17
Pros
I like the simplicity of the software, and the ease of configuration for the user. If a new document type is needed, it's literally just a few clicks away. I like the intuitive navigation and the ease of adoption by the end users.
Cons
At this time, the only place I can fault Qualio is in the data reporting capabilities. Running basics like how many open/closed NCRs or how many SOPs approved is fine, but without more capability built out, or an external API (like a BI report or crystal intelligence tool), I can't get to more data within records. I do know they are working on this however, and generally at the start up level, you're not yet in need of super detailed reporting within your QMS yet anyway. The basics they provide will more than get you off the ground!
Response from Qualio
An intuitive and simple interface is at the core of Qualio's software, so it's fantastic that you've really benefited from this. Thank you for your feedback on our data reporting capabilities too we are looking to rollout improvements to this functionality soon.
- 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 helps lead the way through our MDSAP recertification audit.
Reviewed on 2022-02-01
Qualio serves as my document repository, my "source of truth" for all required records within our...
Qualio serves as my document repository, my "source of truth" for all required records within our 13485/MDSAP compliant QMS. Recertification was completed in 2021 and the auditor noted the speed with which all document records were presented, without a backroom runner!
Pros
Software is easy to use and navigate, and to train others to use at different levels.
Record and report output is quick and organized.
Cons
Software has presented with many fix opportunities. That said the Qualio team is quick to remediate bugs and provide module upgrades that address new user needs!
Response from Qualio
Hi John, congrats on your 13485/MDSAP recertification and we're ecstatic to hear positive feedback from your auditor as well!
- Industry: Medical Devices
- 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 9.0 /10
A useful and up to date QMS for businesses of all shapes and sizes
Reviewed on 2023-08-03
Qualio acts as our eQMS and streamlines our audit trail, document management, and workflows As a...
Qualio acts as our eQMS and streamlines our audit trail, document management, and workflows As a company with employees working in various locations, it is easy to collaborate and find documents. Overall, I do like Qualio. I feel that with time the platform will become even more useful as more features are added.
Pros
I like how Qualio is constantly updating and improving. I particularly like how helpful they are with support, from webinars to onboarding support, you never feel lost of confused. Qualio does exactly what you need it to, and all the extra features are just really nice bonuses.
Cons
There is a learning curve to figuring out Qualio in the beginning. The platform looks pretty simple and basic. but when you try to start doing advanced actions I felt lost. There is a sandbox mode, which is good for playing and learning, but anything you create in the sandbox cannot be moved into your actual account.
- 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 2022-01-27
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: Chemicals
- Company size: 11–50 Employees
- Used Weekly for 2+ years
-
Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support Software
- Likelihood to recommend 10.0 /10
Outstanding eQMS!
Reviewed on 2023-08-03
We control almost every aspect of our manufacturing business in Qualio along with our MES. We love...
We control almost every aspect of our manufacturing business in Qualio along with our MES. We love the system.
Pros
We easily pass cGMP complaince audits utilizing all features of Qualio. The ease of use and being able to quickly pull up any documents requested has impressed many auditors.
Cons
Initially the search feature was a bit clunky, but there has been improvements. No issues now.
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, ComplianceWire, Confluence, Jira, Jira Work Management, Okta, TestRail, Xray
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.
