Qualio or SharePoint? eQMS comparison

The lowdown

Dedicated, specifically designed eQMS tool
Launched 2012
Cloud-based, paperless, market-tested eQMS
Designed for SMEs
Life science focus

Content management system sometimes adapted for eQMS usage
Launched 2001
Cloud-based storage tool which fulfils some quality functions
No customer focus
No industry focus

Features, functionality and usage

Document management


Cloud-based library for storing and controlling QMS documentation with native editing, tagging and templates Version control and GDocP baked in as standard FDA- and EU-compliant e-signatures provided as standard for document activity	Cloud-based access point for storing QMS documentation and organizing in folders Core compliance functionality like version control and change histories missing or limited No built-in e-signature functionality - third-party investment and integration required

Training management

Train users on QMS documents and house training records in a digital repository
E-signatures underpin training activity
Push training, prompts and reminders to users with workflows and track organizational and departmental training status

No native functionality for training employees or capturing evidence of training

Quality event management


Fully configurable workflows for managing any kind of quality event: complaints, CAPAs, change control, deviations	Not a dedicated eQMS and so no event management functionality Documents of event activity could be stored, but no mechanism for pushing, tracking or tracing actions

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 dedicated design control functionality Design elements could be stored as SharePoint documents, but no way to connect these documents, ensure version control, or keep up to date with other data sources without constant manual updates

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 and export Approved Supplier Lists (ASLs) as required	Store supplier documents like contracts, quality agreements and SLAs in bespoke folders No functionality for enforcing supplier quality and compliance policies or tracking supplier statuses Audit records could be attached to suppliers, but would require manual version control and upkeep

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	Easy to use because of basic functionality and familiar Microsoft set-up Performs search and retrieval tasks easily. No way to easily execute other quality management activities without highly manual workarounds and third-party integrations

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	Not a dedicated life science tool with in-house expertise, making you responsible for all validation activity Could require additional consultancy support depending on your in-house expertise and comfort levels Validation and re-validation required by you for every significant system change or update from third-party integrated tools Can be implemented theoretically instantly

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	Extra effort and cost of third-party integrations unavoidable to fulfil modern quality and compliance requirements Rich API integration set, particularly with other Microsoft products

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	Largely basic, inflexible set-up impedes scalability Lack of version control, audit trails and built-in compliance functionality makes usage at scale a risk for regulated businesses

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 online training and access to Microsoft customer support 200m+ users; wait times for support can be substantial Largely intuitive and simple - little or no implementation/training support needed No QA support or QMS documentation templates provided - must be built or bought by the user

Choose Qualio if you:

Want a dedicated life science eQMS tool within 60 days
Want to invest in a long-term tool that makes quality easy
Have plans to launch a high-quality, trusted product to market and comply with relevant regulations
Want to house your entire QMS in a single digital tool that simplifies your quality tasks and automates compliance

Choose SharePoint if you:

Need some kind of QMS document storage instantly
Don't have any budget for a dedicated eQMS
Don't have growth or marketization plans
Can commit to manual upkeep, workarounds and necessary third-party integrations