Cloud eQMS Solution on
Atlassian

The Only eQMS Solution Compliant with both FDA and MDR Regulations

How it works

Screenshot 2023-03-23 at 11.15.39

 


Pricing starts from

Automation
$
60
per month
Apps for workflows and e-signatures
Add Confluence apps for automating document approval workflows with FDA 21 CFR 11 compliant e-signatures. Includes automated Validation app for Confluence Cloud.
Book a Demo
Configuration
$
2900
one-off
Confluence Configuration Service
SoftComply team will configure your Confluence instance for FDA and MDR Compliance, including Test Cases for your in-house validation, with On-Boarding Training of your organisation.
Book a Demo
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

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.

 


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 - Apps for Workflows and E-Signatures
Extend the Compliant Content with available apps on Marketplace for workflows and e-signatures, static snapshots and change history table. With the SoftComply Validation app for Confluence Cloud you can run automated regular integrity checks of your Confluence Cloud instance.
C - Configuration of Confluence Cloud
With the Configuration Service from SoftComply your Confluence Cloud instance is being setup compliantly.

Book a Demo Call


Cloud eQMS Solution on
Atlassian

The Only eQMS Solution Compliant with both FDA and MDR Regulations