Cloud eQMS Solution on
Atlassian

The Only eQMS Solution Compliant with both FDA and MDR Regulations

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
Compliant QMS Content
Get FDA and MDR compliant QMS content from SoftComply eQMS app.
Book a Demo
B - Automation
$
30
per month
Apps for workflows and e-signatures
Add Confluence apps for automating document approval workflows with FDA 21 CFR 11 compliant e-signatures.
Book a Demo
C - Configuration
$
3000
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
+ Validation
$
50
per month
Validation app for Confluence Cloud
To automate regular integrity checks of your Confluence Cloud instance, use the SoftComply Validation for Confluence app.
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Comparison

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

How it works

Screenshot 2022-06-13 at 12.58.13

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.
C - Configuration of Confluence Cloud
With the Configuration Service from SoftComply your Confluence Cloud instance is being setup compliantly.

+ Validation

Validation Service
SoftComply offers validation service of your Confluence Cloud instance and the Cloud eQMS Solution. As a result of the validation service, you will have a full Validation Pack.
OR Automated Validation
SoftComply has released the Validation app for Confluence for automated and regular integrity checks of your Confluence Cloud instance.
Cloud eQMS Solution on
Atlassian

The Only eQMS Solution Compliant with both FDA and MDR Regulations