Qualio or Orcanos?

A balanced eQMS comparison to help you decide





See why our customers prefer us

The lowdown


  • Holistic, integrated eQMS

  • Founded 2012

  • 500+ customers

  • Cloud-based, paperless, market-tested eQMS

  • Supports/simplifies quality and compliance

  • Designed for SMEs

  • Life science focus


  • Dual application lifecycle management/quality management system

  • Founded 2017

  • 100+ customers

  • Cloud-based, paperless, market-tested eQMS

  • Supports/simplifies quality and compliance

  • No customer size focus

  • Medical device/pharmaceutical/electronics/tech focus

Features, functionality and usage

Document management

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  • Cloud-based document library with e-signatures, native editing, tagging and templates

  • Version control and GDocP baked in as standard
  • Cloud-based static PDF library with e-signatures and templates

  • Lack of native editor means documents must be downloaded, edited and re-uploaded

  • Potential integrity and version control weaknesses if used incorrectly

Training management


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  • Train users on eQMS documents and house training records in a digital repository

  • Training tasks generated for system documents and new revisions


Quality event management

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  • Fully configurable workflows in a single area for managing any kind of quality event: complaints, CAPAs, change control, deviations, etc.

  • Editable form templates allow bespoke information capture and response within a scalable, malleable eQMS

  • Fixed system areas for management of CAPAs, complaints and change control

  • Separate ECO module manages engineering change order processes

  • Largely static 'e-form' templates for capturing event information

  • CAPA form could be configured to capture and respond to other types of quality event as a workaround

Design controls

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  • Centralizes and manages all medical device design elements for easy collation of Design History File: ISO 14971 and FMEA risk management, user requirements, open device issues, etc.

  • Pulls design elements automatically from your other testing systems like Jira, Azure DevOps, Asana, Zephyr, Xray or TestRail with plug-and-play API integrations

  • ALM module contains design control functionality, including FMEA and ISO 14971 risk management, test/requirement management and  defect/bug tracking

  • Lack of integration forces all testing activity to be performed within the tool

  • DHF can be automatically generated

Supplier management

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  • Build a configurable database of your supply chain in a dedicated supplier management area

  • Set bespoke policies for manufacturers, service providers, distributors, consultants and more – then use them to enforce supplier requirements and ensure compliance

  • Attach key documents, manage audit details and export Approved Supplier Lists (ASLs) as required

  • Supplier quality management module offers library linking suppliers to related documents, specifications, scorecards, quality events and audits

  • No functionality for enforcing supplier quality and compliance policies, but supplier audits can be scheduled and managed in the audit module

Audit management

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  • Quality event forms and workflows can be configured to capture and respond to audit data

  • Intuitive system UX and visible metrics make it easy to pinpoint weaknesses and demonstrate compliance to external auditors

  • Dedicated audit management module with checklists and finding management

  • 'Virtual auditor' offers compliance KPI feedback to help plug gaps


Equipment management

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  • No dedicated maintenance/calibration functionality, but quality event forms can be configured to capture and respond to equipment and asset data

  • No dedicated maintenance or calibration modules


Ease of use

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  • Designed with natural, intuitive ease of use at the core

  • Clean, minimal UX to maximize user engagement and simplify training and onboarding

  • Consistently ranked the easiest eQMS software to set up and use

  • 'Old-fashioned' and 'non-intuitive' UI with reports of bugs and slow load speed

  • Siloed modular set-up separates design controls from broader QMS and makes cross-system traceability more difficult

  • Customer reviews state 'mindblowing' and overly complex UX complicating system tasks

Implementation & validation

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  • Industry supplier guided by the latest FDA and GAMP computerized system assurance (CSA) guidelines for a rapid, least burdensome validation approach for customers

  • Validation document pack provides all objective functional evidence of system suitability. Customers need only perform extra software testing if they feel it’s risk-appropriate

  • Average implementation time frame: 60 days

  • Uses outdated IQ-, OQ- and PQ-based validation now superseded by latest best practice

  • Complex dual structure requires more testing and validation work, resulting in a longer implementation timeframe based on your package complexity

  • New releases not always sufficiently quality-tested - product faults and bugs could damage customer compliance and system integrity


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  • Designed to seamlessly connect to your other business-critical tools. Keeps your teams in their familiar, specialized systems while the eQMS absorbs real-time data from them

  • Plug-and-play API integrations with Salesforce, Jira, Zephyr, Xray, Azure DevOps, Asana, TestRail and ComplianceWire, with NetSuite integration on the way

  • Integration with Salesforce, Jira, 365, Zapier and Teams only

  • Limited device design tool integrations despite medical device focus


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  • Designed to ‘grow with you’ and guide your business up the quality maturity curve to marketization and beyond

  • Flexible, configurable make-up makes tweaking processes, adding new users and scaling up the QMS quick and easy

  • Unlimited free basic document and training access turns Qualio into a business-wide quality tool

  • Modular, inflexible set-up impedes scalability

  • Less intuitive UI may impede wider adoption and long-term scalability

  • Modular pricing may be cost-prohibitive for companies wanting to expand into new system areas

Customer support

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  • Commits to a long-term partnership with customers. Customer success managers, plus high-touch 24/7 support from team members in the US and EMEA with live chat and Help Center

  • Qualio+ package provides targeted QA expert support and pre-built standard-specific system templates to accelerate compliance

  • High marks from customers for responsiveness, level of support, and general satisfaction

  • Offers product and technical support

  • No QA support or QMS documentation templates provided

  • Based solely in Israel; no domestic support for international customers

  • Customer reports of long waits for issue and bug resolutions

Choose Qualio if you:

  • Are a life science company

  • Want a single, integrated eQMS with all required functionality

  • Want a flexible, scalable and robust system that grows with you

  • Want your eQMS to integrate with multiple tools and be easily adopted business-wide

Choose Orcanos if you:

  • Are a tech or electronics company

  • Need dedicated audit management functionality

  • Want a fixed, modular eQMS structure

  • Don't need multiple integrations or wide business adoption