Qualio or Orcanos? eQMS comparison

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


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

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


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


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


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

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

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


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


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

Ecosystem


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

Scalability


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


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