Qualio
About 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.
Key benefits of 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!
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Reviews
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- Industry: Medical Devices
- Company size: 51–200 Employees
- Used Daily for 2+ years
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Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support
- 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: Semiconductors
- Company size: 11–50 Employees
- Used Daily for 2+ years
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Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support
- Likelihood to recommend 10.0 /10
Qualio Implementation, QMS Creation, and ISO Audit.
Reviewed on 2024/04/17
Great experience, allowed me implement a company wide QMS, passing ISO registration audits both...
Great experience, allowed me implement a company wide QMS, passing ISO registration audits both times.
Pros
Simple but complex at the same time, great features.
Cons
Docuemnt formatting could be improve, but very good currently.
- Industry: Medical Devices
- Company size: 51–200 Employees
- Used Daily for 6-12 months
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Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support
- Likelihood to recommend 7.0 /10
Qualio has potential
Reviewed on 2024/04/12
Overall I think Qualio has a lot of potential. It has a lot of functions which just need slight...
Overall I think Qualio has a lot of potential. It has a lot of functions which just need slight improvements before they can be fully effective.
Pros
I like the version control of documents and that minor changes can be made without sending the document for re-training. Customer service is exceptional with issue and queries being addressed as soon as possible.
Cons
The 'compare against' function is not very useful as often it highlights entire sections of text instead of the specific changes. It also shows code when changes are made to tables or images.
The inability to revision control templates directly.
If templates update, changes within sections have to be applied manually to documents in draft.
- Industry: Food & Beverages
- Company size: 201–500 Employees
- Used Daily for 1+ year
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Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support
- Likelihood to recommend 8.0 /10
Start up company with Qualio
Reviewed on 2024/04/17
Overall very happy, but it is my understand there may be some very significant price increases...
Overall very happy, but it is my understand there may be some very significant price increases coming our way which could cause us to look at alternate systems
Pros
*Customer Service
*Ease of initial installation
*Sandbox feature
Cons
*Suppliers module
*Improvement suggestions not always acted up efficiently
- Industry: Medical Devices
- Company size: 2–10 Employees
- Used Daily for 2+ years
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Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support
- Likelihood to recommend 9.0 /10
AMM Qualio Review
Reviewed on 2023/08/08
My overall experience with Qualio is good. It has helped our company grow and pass many audits. It...
My overall experience with Qualio is good. It has helped our company grow and pass many audits. It also helped us reduce a headcount by serving as a document control solution. Qualio solves our companies Quality Management Software needs and helps us to maintain all of our documents in a controlled system. Qualio also helps us organize our training and events such as CAPA's and NCMR's.
Pros
The user interface is very good. It is easy to train new people how to use Qualio.The file organization and linking abilities from documents within documents is very good.
Cons
I do not like how the change control history only limits you to see the last change control. If you want to see previous change control history of older versions of a document you have to create a draft and delete it once you are finished.
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:
- Free Trial: Not Available
Please contact Qualio for pricing details.
Q. Who are the typical users of Qualio?
Qualio has the following typical customers:
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, Okta, TestRail, Xray
Q. What level of support does Qualio offer?
Qualio offers the following support options:
Email/Help Desk, FAQs/Forum, Knowledge Base, Phone Support, 24/7 (Live rep), Chat
Related categories
See all software categories found for Qualio.
Quality Management Software
