The Only Compliant and Affordable eQMS Solution on
Atlassian

The Only Cloud eQMS Solution Compliant with both FDA and MDR Regulations on Atlassian

Cloud eQMS Solution combines your Quality System Documents with FDA 21 CFR 11 Compliant Document Approval Workflows for Medical Device Companies on Atlassian Confluence Cloud.

 

 

 

Pricing starts from

A - QMS Content
$
2400
one-off (if needed)
Compliant QMS Content
Get FDA and MDR compliant QMS content from SoftComply eQMS app. Over 25 SOPs and 75 Technical Document Templates - pre-filled with embedded guidance.
Book a Demo
B - SoftComply Document Manager
$
47
per month
App for Workflows and E-signatures
Confluence app for automating Document Approval Workflows with FDA 21 CFR 11 Compliant E-signatures: SoftComply Document Manager on Confluence Cloud.
Book a Demo
C - Validation for Confluence Cloud
$
50
per month
Regular Integrity Checks of Confluence Cloud
Confluence app to run automated Validation tests of your Confluence Cloud instance 1 x a week generating full Validation Documentation pack as a result of each test run.
Book a Demo
Configuration
$
1000
one-off
Confluence Configuration Service & Onboarding Training
SoftComply team configures your eQMS Content as needed, and provides an On-Boarding Training of the Solution to your organisation.
Book a Demo

 


Comparison

FEATURE
Best Fit for SaMD (Software as a Medical Device)
Possibility to Trial
SME Price Range
Bi-Directional Integration with Jira
MasterControl
✓
✕
✕
✕
SoftComply Cloud eQMS
✓
✓
✓
✓
Greenlight Guru
✕
✕
✓
✕
Qualio
✕
✕
✓
✕

Cloud eQMS Solution Architecture

A - Compliant QMS Content
SoftComply eQMS provides a full compliant QMS documentation with 22 SOPs, 77 technical document templates, a Quality Manual and a Quality Policy. Pre-filled with embedded guidance based on ISO13485, IEC 62304, ISO 14971 and FDA 21 CFR 820.
B - SoftComply Document Manager
Automate your Document Approval Workflows and e-Signatures with the SoftComply Document Manager app for Confluence.
C - Validation of Confluence Cloud
Run automated Validation tests of your Confluence Cloud instance 1 x a week generating full Validation Documentation pack as a result of each test run.

Book a Demo Call


Cloud eQMS Solution on
Atlassian

The Only eQMS Solution Compliant with both FDA and MDR Regulations