SoftComply eQMS - Compliant QMS in Confluence
FDA, MDR, TGA & Canada MDR Compliant Quality System based on ISO13485, IEC62304, ISO14971, FDA 21 CFR 820
Extend the Content into a full Cloud eQMS Solution
A Fully Customizable Quality Management System
Limited trial view of a Quality Management System for Medical Devices. Based on ISO 13485, IEC 62304 & 21 CFR820, the eQMS fast-tracks the development of organization’s procedures and processes for regulatory compliance.
Embedded Guidance for Customizing Your QMS
The SoftComply eQMS comes with a complete “Example QMS” taken from real industry cases. Info-boxes, Warnings and Notes suggest best practices on how to make the best use of your Quality System.
Based on ISO13485, IEC62304, FDA 21CFR 820 & TGA, the SoftComply eQMS fast-tracks the development of organisation’s procedures for compliance - a full Quality System for medical device companies.
Includes a Quality Manual, Quality Policy, 25 SOPs & 77 templates pre-filled to fast-track the implementation of QMS.
Fully customisable with guidance on finalising the documents.
The fastest path to a compliant Quality System.
BOOK A LIVE DEMO to view the entire eQMS content & to learn how we can help customise your Confluence instance with compliant document workflows and e-signatures. CHECK OUT RECORDINGS of the eQMS solution.
Automate your regular Confluence integrity checks with our Validation app for Confluence Cloud.
To manage your product risks, check out our Risk apps on Jira.
Privacy and security
SoftComply eQMS - Compliant QMS in Confluence integrates with your Atlassian product. This remote service can:
- Read data from the host application