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

Supported Languages

English

Pricing starting from:

Not provided by vendor

  • Free Version
  • Free Trial
  • Subscription

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
Qualio Software - Seamless requirements management
View 9 more
Qualio video
Qualio video
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
Qualio Software - Seamless requirements management

Features

Total features of Qualio: 71

  • API
  • Access Controls/Permissions
  • Action Management
  • Activity Dashboard
  • Activity Tracking
  • Alerts / Escalation
  • Alerts/Notifications
  • Approval Process Control
  • Archiving & Retention
  • Audit Management
  • Audit Planning
  • Audit Trail
  • Automated Routing
  • Change Management Software
  • Collaboration Tools
  • Commenting/Notes
  • Communications Management
  • Complaint Management Software
  • Compliance Management
  • Compliance Tracking
  • Controls Audit
  • Corrective and Preventive Actions (CAPA)
  • Customizable Forms
  • Customizable Reports
  • Customizable Templates
  • Dashboard Software
  • Data Import/Export
  • Data Visualization Software
  • Defect Tracking
  • Digital Signature Software
  • Document Coding & Control
  • Document Management Software
  • Document Review
  • Document Storage
  • Document Templates
  • Drag & Drop
  • Electronic Signature
  • Environmental Compliance
  • Equipment Management
  • FDA Compliance
  • File Management
  • Forms Management
  • HIPAA Compliant
  • ISO Compliance
  • ISO Standards Management
  • Incident Management Software
  • Inspection Management
  • Issue Management
  • Maintenance Management Software
  • Monitoring
  • Nonconformance Tracking
  • Periodic Review
  • Quality Assurance
  • Quality Control
  • Real Time Analytics
  • Real Time Data
  • Real Time Reporting
  • Real-time Updates
  • Reminders
  • Reporting & Statistics
  • Risk Assessment
  • Risk Management Software
  • Role-Based Permissions
  • Supplier Management
  • Supplier Quality Control
  • Task Management Software
  • Third Party Integrations
  • Traceability
  • Training Management
  • Version Control
  • Workflow Management Software

Alternatives

MasterControl Quality Excellence

4.5
#1 Alternative to Qualio
MasterControl is an electronic quality management software (eQMS) system compliant with FDA regulations and ISO quality...

Greenlight Guru

4.5
#2 Alternative to Qualio
Greenlight Guru helps medical device businesses create, launch, and manage custom workflow templates to streamline...

Veeva QualityOne EQMS

4.7
#3 Alternative to Qualio
QualityOne provides a unified solution for quality management, document control, and training, allowing users to manage...

Document Control

4.4
#4 Alternative to Qualio
MediaLab's Document Control enables laboratories to take control of documents & procedure manuals, meeting CAP, CLIA,...

Reviews

Overall rating

4.7 /5
(63)
Value for Money
4.6/5
Features
4.3/5
Ease of Use
4.6/5
Customer Support Software
4.8/5

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

Write a Review!
Showing 5 reviews of 63
Atul Pratap
Overall rating
  • 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 2022-08-10

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.

Mickey
Overall rating
  • 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 2022-01-27

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.

Irma
Overall rating
  • 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 Control

Reasons for Switching to Qualio

Price

Response from Qualio

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

Santino
Overall rating
  • Industry: Education Management
  • Company size: 501-1,000 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Ease of Use
  • Likelihood to recommend 9.0 /10

Qualio Review

Reviewed on 2022-06-01

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
Overall rating
  • 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 2022-02-02

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.

Showing 5 reviews of 63 Read all reviews

Qualio FAQs

Below are some frequently asked questions for Qualio.

Qualio offers the following pricing plans:

Please contact Qualio for pricing details.

Qualio has the following typical customers:

Self Employed, 2-10, 11-50, 51-200, 201-500

Qualio supports the following languages:

English

Qualio supports the following devices:

Qualio integrates with the following applications:

Asana, Azure DevOps Services, Confluence, Jira, Jira Work Management, Okta, TestRail

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.