Qualio or Scilife? eQMS comparison

The lowdown

Document management


Cloud-based document library with all modern functionality such as e-signatures and version control 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 version control No in-system editing; documents must be updated through Word integration

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	Separate 'Trainings' and 'Competences' modules allow staff training to be scheduled, completed and recorded Push training, prompts and reminders to users with workflows and track organizational and departmental training status

Quality event management


Fully configurable workflows in a single area for managing any kind of quality event: complaints, CAPAs, change control, deviations	Separate modules with fixed workflows for deviations/NCRs, CAPAs and change control Quality Process Designer module allows workflow configuration, but unclear how this links with the other event management modules (potential siloing/duplication)

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 Product Development module promised to customers since 2021, but yet to appear and unclear if it will offer all required design control functionality

Audit management


Quality event forms and workflows can be configured to capture and respond to audit data Entire system contributes to audit readiness by offering a controlled, audit-trailed repository of eQMS data accessible with ease	Dedicated module for managing audit completion, including form completion and finding capture Same overall functionality as Qualio

Equipment management

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

Dedicated module for recording equipment and scheduling maintenance/calibration tasks

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 Build configurable workflows for onboarding and assessing 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, colorful, gamified interface Scored highly for user friendliness by customers, but modular structure and some UX quirks add friction

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

Modules positioned as 'pre-validated' - potentially misleading labeling which ignores the latest industry expectations of validation activity on the customer side
Taking all 15 modules could require a large amount of customer validation work, particularly for modules with configurable workflows (Quality Process Designer, Supplier Management)
Reliance on Microsoft Word for document editing adds an extra layer of validation considerations - feature-dense, auto-updated third-party tool governs document activity

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	Younger, less established product with fewer integrations and less mature ecosystem Integrates with Office and Azure Active Directory

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	Ease of use and 'pick and mix' modules with low pricing conducive to scalability Very young company and product; modules still in the pipeline and not immediately available for ramp-up Siloed modular structure makes scaling a holistic quality approach more difficult Company is very small itself (approx. 35 staff) and may not be equipped to service growing organizations

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

Offers customer success manager, onboarding services, 1-2-1 training
Small young company: needs high customer satisfaction to grow, but may have less support bandwidth than larger organizations
Originally founded as QbD Software, an eQMS built by Belgian life science consultants - should have in-house life science expertise
No QA support packages or QMS content provided

Are a life science SME with growth ambitions
Need product management functionality, including medical device design controls
Want an integrated, holistic life science eQMS
Want an established, scalable, market-trusted product with over ten years of customer usage