Goodbye eQMS, hello iQMS !
Qity iQMS is not just an eQMS, but a complete ecosystem for Medical Device Development.
Qity iQMS embeds a Quality Management System in the tools you use every day to develop your product and organize your work, effectively minimizing the paper work and regulatory burden.
Strengths
Familiar tools, customised for compliance
Built on Jira, Confluence, and Bitbucket (used by 170,000+ companies), enriched with Qity's innovative apps, templates, automation, specifically configured for regulatory compliance.
Document Control in Confluence and Jira
Say goodbye to importing/exporting documents into a separate Document Control System!
Qity's compliant Document Control System is exactly where it is supposed to be: the space where you write, collaborate and review your documents.
Grows with your organization
Qity's modular iQMS is tailored to the specific needs of your company, ensuring the right level of compliance at each stage of your product development.
Select the subscription plan tailored to your organization's needs.
Automation, the future of regulatory product development
Dramatically reduce turn-around time of quality activities, by automating software and hardware tests with calibrated equipment, and testing your designs using modelling and simulation tools. Documentation (e.g. test reports) is automatically generated in the Quality Management System.
Complete traceability and audit trail
Unparalleled control and traceability, offering comprehensive compliant audit trail, full change tracking, detailed review commentary, for ultimate accountability and continuous audit-readiness.
Foundation Plan
Develop a proof of concept
Document Control
Architecture & Design
Product Development Lifecycle
Risk Management
Management Responsibility
Prototyping Plan
Design your product
Everything in Foundation Plan
+
Design Verification
Purchasing
Supplier Management
Facility Management & Infrastructure
Human Resources
Pilot Plan
Manufacture for compliance testing
Everything in Prototype Plan
+
Design Validation
Change Control
Audit
Equipment
Training
CAPA
Non-Conformng Products
Receiving & Incoming Inspection
DHF, DMR & Technical File
Commercial Plan
Launch your product
Everything in Pilot Plan
+
DHR
Pre/Post-Market Surveillance
Order Management
Problem Reporting & Submission
Recalls & Advisory Notes
Global Atlassian Partner
As a global Atlassian Partner, we are qualified to set up and maintain your platform.
We stay on top of the latest developments from Atlassian and evaluate everything in-house before deploying to a customer.
Frequently Asked Questions
Is Qity iQMS validated?
Is Qity iQMS GDPR compliant?
Is Qity iQMS FDA 21 CFR Part 11 compliant?
Is customer support included in the monthly license fee?