Qualio or SoftComply? eQMS comparison

The lowdown

Holistic, integrated eQMS
Founded 2012
600+ customers
Cloud-based, paperless eQMS
Supports/simplifies quality and compliance
Designed for SMEs
Life science focus

Provides two Atlassian apps: Risk Manager Plus and SoftComply eQMS
Founded 2016
1000+ customers
Paperless cloud-based quality apps
Supports/simplifies quality and compliance
Designed for SMEs
Medical device/SaMD focus

Features, functionality and usage

Document management

Cloud-based document library with e-signatures, tagging, templates, review/control workflows, etc.
Documents edited and collaborated on within the system

SoftComply eQMS focuses almost entirely on documents: all main lifecycle management functionality included
No native editing or collaboration - documents must be downloaded, edited and re-uploaded
Separate Change History module pulls document approval histories from Comala into your Confluence documents

Training management


Train users on eQMS documents and house training records in a digital repository Assessments test understanding and prove operational compliance Build and cascade Training Plans for proactive team training	eQMS contains designated area for storing training records, but no functionality for training on eQMS documentation No functionality for planning or cascading training Storage rather than execution

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	Editable document templates for events like CAPAs and complaints can be populated to generate event records Limited configuration of workflows for routing actions and closing out events

Design controls


Dedicated design control area 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	No dedicated design control functionality - major omission for an eQMS focused on medical devices Document templates could be used to generate and store documents like a DHF, but no visual collection or management of design data in-system Separate Risk Manager Plus system can be used for design activities like FMEA and risk report generation

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	No supplier management functionality beyond storing supplier record documents Risk Manager Plus could be used to record supplier risks

Analytics


Rich analytic dashboards for at-a-glance visibility of document, training, event and supplier management activity Dive into visual eQMS data to spot trends, fix bottlenecks and more	No analytic functionality

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	Dated Confluence UX: cluttered, complicated structure Would be easier for seasoned Confluence users to adapt to Adapted application in a broader system not specifically designed for eQMS usage

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	Validation app offered separately: automated weekly integrity checks plus generation of validation report Requires addition of extra apps to broaden functionality - more validation required each time

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	Atlassian application, and so integrates easily with Jira and Confluence Limited integration between SoftComply eQMS and Risk Manager Plus apps No other integrations out-of-the-box

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 eQMS quick and easy Unlimited free basic document and training access turns Qualio into a business-wide quality tool	Complicated UI may impede wider adoption Modular, multi-app structure allows expansion as required, but with additional costs Not a purpose-built eQMS - can only scale so far

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	Online Help Center and Service Desk - responses likely to be slower due to size of Atlassian user base Pre-built medical device QMS document templates available for one-off purchase - no additional quality and compliance support Compliance and Atlassian usage courses available for an additional fee

Choose Qualio if you:

Need a holistic, purpose-built eQMS for life science start-ups and scale-ups
Want a flexible eQMS to tailor to your exact business needs
Want to integrate your eQMS with multiple tools like CRM and design platforms
Want ease of use, high-touch quality and system support, and high user engagement at the center of your eQMS adoption

Choose SoftComply if you:

Only need document functionality
Want a basic eQMS built on Confluence
Want an eQMS connected to Atlassian tools like Jira
Don't need dedicated eQMS functionality for suppliers, design controls, in-app document editing, analytics and so on