Qualio or Dot Compliance? eQMS comparison

The lowdown

Document management

Cloud-based document library with all modern functionality such as e-signatures and viewing permissions
In-system editing with version control and GDocP baked in as standard

Cloud-based document library with all modern functionality such as e-signatures and viewing permissions
No in-system editing; documents must be checked out, updated and checked in through Word integration, with potential integrity weaknesses if used incorrectly
System displays superseded SOPs and overwrites custom numbering - potential version control and traceability weaknesses without full awareness
Some customer reports of long search and load times, and clunky review processes

Training management


Train users on QMS documents and house training records in a digital repository Push training, prompts and reminders to users with workflows and track organizational and departmental training status	Train users on QMS documents and house training records in a digital repository Push training, prompts and reminders to users with workflows and track organizational and departmental training status Open training not readily visible from system Dashboard; must be searched for

Quality event management


Fully configurable workflows in a single area for managing any kind of quality event: complaints, CAPAs, change control, deviations, etc.	Separate siloed modules for deviations/NCRs, CAPAs, change control and other events Some customer reports of complex, difficult-to-understand workflow building

Design controls


Centralizes and manages all medical device design elements for easy collation of Design History File Pulls design elements automatically from your other testing systems like Jira, Azure DevOps, Asana, Zephyr, Xray or TestRail with plug-and-play API integrations	No design control functionality Risk management module could provide some device risk control, but not the full range of design controls

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, nominate approvers and export Approved Supplier Lists (ASLs) as required	Add and manage suppliers in the supplier management module Track quality events linked to suppliers

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 use by life science quality professionals	Modern interface built on Salesforce platform Customer reports of steep learning curve and usability quirks - considerable training required during system set-up for full adoption

Implementation & validation

Modern validation approach: guided by the latest FDA and GAMP computerized system assurance (CSA) guidelines for a rapid, least burdensome experience 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
Ranked the easiest eQMS to set up by real G2 reviewers

System positioned as 'fully validated' - potentially misleading labeling which ignores the latest industry expectations of validation activity on the customer side
Taking all 11 modules could require a large amount of customer validation work
Reliance on Microsoft Word for document editing adds an extra layer of validation considerations - feature-dense, auto-updated third-party tool governs document activity
Some customer reports of incomplete training and implementation, damaging adoption and sentiment

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	Built on Salesforce platform with open API Website mentions 'AI', 'IoT' and 'Big Data' integrations, but unclear what this means in practice

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 Established, market-tested product with all functionality available now	Tiered system structure for companies to scale through: QMS Xpress, Compliance Xpand, Enterprise Xact Tiered pricing could add a ceiling to scalability, depending on your budget Siloed modular structure and usability learning curve could make scaling a holistic quality approach more difficult

Customer support

Commits to a long-term partnership with customers. Onboarding/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

Want an integrated, holistic life science eQMS to scale with you
Need medical device design control functionality
Want an established, market-trusted product with over ten years of customer usage
Want the easiest eQMS to set up, use and extract value from