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Qualio Logo

Cloud-based quality management tool for life science firms.

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Qualio - 2026 Pricing, Features, Reviews & Alternatives

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All user reviews are verified by in-house moderators and provider data by our software research team.  Learn more

Last updated: December 2025

Qualio overview

What is Qualio?

Qualio is a quality management solution offering key features such as document management, access controls/permissions, corrective and preventive actions (CAPA), and document storage, among others.

Key benefits of using Qualio

  • Built for medical device, pharmaceutical, biotech and contract research/manufacturing organizations
  • Manage quality documentation, training, CAPAs, deviations, change control, suppliers, medical device design controls and more<br/><li> In-app document editing for total control of your document lifecycle<br/><li> Connect the entire business to a single source of quality trust backed by powerful analytics and full audit traceability<br/><li> Stay compliant with real-time and detailed insights into documents, people and actions

  • Who uses Qualio?

    By industry, Qualio reviewers are most commonly professionals in medical devices (36%). The most frequent use case for Qualio cited by reviewers is quality management (81% of reviewers).

    Starting price

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    Pros & Cons

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    Training and Learning Curve

    SOP Control

    Compliance Reminders

    Document Drafting

    Text Formatting

    Qualio’s user interface

    Ease of use rating:

    Qualio pros, cons and reviews insights

    To determine these pros and cons insights, we analyzed responses from 

    Overall rating

    Reviews sentiment

     
     
     
    1-2(1)
    3-4(44)
    5(82)

    What do users say about Qualio?

    Qualio is a quality management solution offering key features such as document management, access controls/permissions, corrective and preventive actions (CAPA), and document storage, among others.

    Select to learn more


    Who uses Qualio?

    Based on 127 verified user reviews.

    Company size

    Small Businesses

    Enterprises

    Midsize Businesses

    Top industries

    Medical Devices
    Biotechnology
    Pharmaceuticals
    Research
    Others

    Use cases

    Quality Management
    Document Control
    Document Management
    Compliance
    Corrective and Preventive Action

    Qualio's key features

    GetApp's analysis of 43 verified user reviews collected between January 2022 and May 2024 identifies Qualio's most critical features and summarizes user sentiment about those features.

    Document management

    Reviewers appreciate Qualio's document management capabilities for their ease of traceability, retrieval, and online reviews with comments. They find the ability to link related documents and maintain a clear audit trail valuable. Users report that Qualio supports ISO and GMP compliance, though some mention issues with draft control. They highlight the ease of creating, editing, and sharing digital documents, and the helpful sorting options by type, name, and author. They say document templates and lifecycle management enhance efficiency. Of the 19 Qualio users who gave detailed accounts of their use of Document Management, 100% rated this feature as important or highly important.

    See related user reviews

    “Ease of documents traceability and retrieval, Reminders for periodic review ensuring timely reviews Related documents can be linked in one document. Online reviews of documents with review comments and suggestions.”
    HN

    Hanifa N.

    Quality Assurance Officer

    “Again, the way documents are managed is one of Qualio's best features. It is so easy to sort by type, name, author, etc. This feature is useful, helpful, and makes document processes much more efficient.”
    VS

    Victoria S.

    Laboratory Technician


    Access controls/permissions

    Reviewers indicate that Qualio's access controls and permissions are beneficial for managing user roles and ensuring data security. They appreciate the ability to modify, assign, and remove users, and the different access levels for various user types. Users report that this capability is important for incident management and audits, and they value the unique login credentials for each user. They find it easy to control user access and assign training, though some suggest additional access levels and approval steps for drafts. Of the 20 Qualio users who gave detailed accounts of their use of Access Controls/Permissions, 100% rated this feature as important or highly important.

    See related user reviews

    “Some material is deemed sensitive and therefore access control and permission allow me to dictate the user experience and privileges. This is incredibly important for incident management and related audits. ”
    KP

    Karl P.

    Quality and Compliance Director

    “Has user levels and each user has a unique login credentials ”
    CD

    Caldin D.

    Quality control manager


    Corrective and preventive actions (capa)

    Users report that Qualio's CAPA capabilities are robust and essential for compliance and product development. They appreciate the ability to create, monitor, and close CAPA actions using the Event tracker. Reviewers indicate that the customization of templates to match internal processes is helpful, and they value the real-time review and approval with set timelines. They find it easy to link CAPAs to relevant documents and track progress, though some mention the capability can be complicated. Of the 21 Qualio users who gave detailed accounts of their use of Corrective and Preventive Actions (CAPA), 95% rated this feature as important or highly important.

    See related user reviews

    “We have built o robust CAPA system using Qualio's Event tracker where we can create, monitor, and close out and CAPA actions that have been raised.”
    TD

    Thomas D.

    QA Engineer

    “CAPA's are a critical part of compliance. The ability to customize the template to match internal processes makes it easy. It is also easy for the regulatory auditors to follow.”
    KS

    Kim S.

    Quality Specialist


    Document storage

    Reviewers feel that Qualio's document storage is effective for organizing and accessing documents securely. They appreciate the ability to store all materials, specifications, forms, and CAPAs in one place, ensuring compliance with ISO 13485. Users report that the cloud-based storage offers large capacity and quick access for editing and consulting. They find the organization of documents easy to understand and transfer between personnel, and they value the high safety and traceability of stored documents. Of the 20 Qualio users who gave detailed accounts of their use of Document Storage, 90% rated this feature as important or highly important.

    See related user reviews

    “Product-related information can be collected in one or linked files, preventing the information's loss. All materials specifications, forms, SDS, and CAPA are easy to maintain and find. ”
    HY

    Halyna Y.

    QA Senior Scientist

    “Ensures documents can be quickly accessed for editing and consulting.”
    LF

    Luke F.

    Lifescience Compliance Specialist


    All Qualio features

    Features rating:

    Monitoring
    Real-Time reporting
    Environmental compliance
    Risk analysis
    Document review
    Risk management
    Document coding & control
    Data visualization
    Single sign on
    User management
    Workflow management
    Assessment management
    Electronic signature
    Version control
    Archiving & retention
    Secure data storage
    Change management
    Compliance tracking
    Audit trail
    Incident management
    ISO standards management
    Quality control
    Compliance management
    FDA compliance
    Collaboration tools
    Customizable reports
    Content management
    ISO compliance
    Training management
    Defect tracking
    Risk assessment
    Audit management
    Equipment management
    Communications management
    Complaint management
    Issue management
    Audit planning
    Maintenance management
    Real-Time data
    Real-Time notifications
    Real-Time analytics
    Real-Time updates
    Policy management
    Reminders
    Reporting & statistics
    Revision history
    Trend analysis
    Training administration
    Third-Party integrations
    Role-Based permissions
    Root cause analysis
    Rules-Based workflow
    Search/Filter
    Status tracking
    Supplier management
    Supplier quality control
    Tagging
    Task management
    Activity dashboard
    Activity tracking
    Alerts/Escalation
    Alerts/Notifications
    API
    Approval process control
    Approval workflow
    Change planning
    Commenting/Notes
    Configurable workflow
    Course management
    Customizable branding
    Customizable forms
    Customizable templates
    Dashboard
    Data import/export
    Document automation
    Document capture
    Document generation
    Document lifecycle management
    Document templates
    Drag & drop
    Email alerts
    File management
    File sharing
    Forms management
    Full text search
    Governance
    HIPAA compliant
    Inspection management
    Nonconformance tracking

    Qualio awards

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    Qualio logo
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    Empty state illustration for "No pricing info"

    No pricing info

    Free trial
    Free version
    Ease of Use
    Features
    Value for Money
    Customer Support

    Qualio pricing

    Value for money rating:

    Pricing plans

    Pricing details:

    Free plan
    Free trial
    Subscription

    Foundation

    Empty state illustration for "No pricing info"

    No pricing info

    Features included:

    • Documents
    • Training
    • Design controls
    • Standard integrations
    • Analytics
    • Centralized management
    • Custom workflow
    • Quality events

    Growth

    Empty state illustration for "No pricing info"

    No pricing info

    Features included:

    • Suppliers
    • AI assistant

    Scale

    Empty state illustration for "No pricing info"

    No pricing info

    Features included:

    • Premium integrations

    User opinions about Qualio price and value

    Value for money rating:

    To see what individual users think of Qualio's price and value, check out the review snippets below.

    “The Customer Service both supporting the induction of the platform and the every day query customer service is outstanding and could not compliment them more.”
    KP

    Karl P.

    Quality and Compliance Director

    “Easy to use with a very intuitive user interface, compliance with CFR 21 part 11, outstanding customer support, swift document navigation.”
    JT

    Jonas T.

    Quality Manager

    Qualio integrations (18)

    Integrations rated by users

    We looked at 127 user reviews to identify which products are mentioned as Qualio integrations and how users feel about them.

    Jira logo
    Jira

    Integration rating: 3.0 (1)

    Qualio customer support

    What do users say about Qualio customer support?

    Customer support rating:

    We analyzed 20 verified user reviews to identify positive and negative aspects of Qualio customer support.

    Widespread user sentiment highlights Qualio's customer support as responsive, knowledgeable, and easy to contact.

    A large number of users found the support team instrumental during onboarding, migrations, and issue resolution.

    Support options

    Email/help desk
    Chat
    Knowledge base
    Phone support
    Faqs/forum
    24/7 (live rep)

    Training options

    Live online
    Videos
    Documentation
    Webinars

    To see what individual users say about Qualio's customer support, check out the review snippets below.

    “The Customer Service both supporting the induction of the platform and the every day query customer service is outstanding and could not compliment them more. ”

    KP

    Karl P.

    Quality and Compliance Director

    “The built-in chat function for fast support is excellent - so easy to use. ”

    jf

    jared f.

    Director, Strategic Projects

    “A really important fact is that the support team at Qualio is about the best I have seen in the industry. ”

    LA

    Laura A.

    VP, Quality

    Qualio FAQs

    Q. Who are the typical users of Qualio?

    Qualio has the following typical customers:
    Freelancers, Large Enterprises, Mid Size Business, Small Business


    Q. What is Qualio used for?

    Qualio is a cloud-based quality management software designed specifically for life science companies seeking to maintain regulatory compliance while optimizing their quality processes. The platform offers comprehensive functionality through an intuitive user interface that prioritizes ease of use, collaborative content management, and seamless connectivity between internal teams and external stakeholders. This electronic quality management system (eQMS) enables organizations to digitize and organize their entire document stack, implement effective design controls, manage risks, track training, control changes, prepare for audits, handle CAPAs and non-conformances, oversee suppliers, analyze quality metrics, and maintain pharmacovigilance and post-market surveillance. The software provides specialized solutions for various segments of the life science industry, including medical devices, pharmaceuticals, biotech, cannabis, cosmetics, software as medical device (SaMD), and contract research organizations. Qualio supports compliance with multiple regulatory frameworks such as FDA requirements, ISO standards (9001 and 13485), ICH guidelines, CE marking, UKCA marking, and MDSAP certification. The system integrates with business-critical applications to automate workflows and create a unified source of truth for quality data, enabling organizations to maintain continuous compliance in an environment of changing regulations. Qualio delivers measurable performance improvements for its users, including faster quality processes, significant reductions in quality administration time, increased product release speed, and more efficient external audits. The platform's effectiveness is demonstrated through high customer satisfaction metrics, with the majority of users reporting Qualio as a trusted partner that provides more scalable quality processes, greater confidence during regulatory audits, improved quality efficiency, and enhanced company-wide engagement with quality initiatives. The software accommodates organizations of various sizes, from small startups to large enterprises with over five hundred employees. Qualio transforms quality management from a departmental function into an organizational culture, making quality processes natural, automatic, and integrated throughout the business. By simplifying complex compliance requirements and streamlining quality operations, the software helps life science companies accelerate their path to market while maintaining the highest standards of quality and regulatory compliance. This comprehensive approach to quality management provides organizations with a competitive advantage in the highly regulated life science sector, where quality excellence is paramount to success.


    Q. What languages does Qualio support?

    Qualio supports the following languages:
    English


    Q. Does Qualio offer an API?

    Yes, Qualio has an API available for use.


    Q. What level of support does Qualio offer?

    Qualio offers the following support options:
    Email/Help Desk, Chat, Knowledge Base, Phone Support, FAQs/Forum, 24/7 (Live rep)

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