SOFTCOMPLY eQMS ON
Atlassian

SoftComply eQMS is a Quality Management System packaged as an app on Confluence.

Compliant with both the FDA & the MDR Regulations.

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SoftComply eQMS customers include




Pricing starts from

Cloud
$
2400
One-off
Full QMS Documentation
SoftComply eQMS has a Quality Manual, a Quality Policy, 22 SOPs and 77 document templates pre-filled to fast-track the development and implementation of your QMS. Just add your company and product development details!
Extendable to the CLOUD eQMS SOLUTION
SoftComply eQMS is fully integrated to Atlassian Confluence and can easily be extended to the FDA 21 CFR 11 and MDR compliant CLOUD eQMS SOLUTION.
Compliant with both FDA and MDR
SoftComply eQMS is compliant with both the FDA and the MDR regulations.
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Data Center
$
4500
per year
Full Quality Management System
SoftComply eQMS has a Quality Manual, a Quality Policy, 22 SOPs and 77 document templates pre-filled to fast-track the development and implementation of your QMS. Just add your company and product development details!
Embedded Guidance
SoftComply eQMS contains embedded guidance on how to customise the SOPs and technical documents according to your company and the device.
Example QMS
SoftComply eQMS contains a completed Quality Management System, an Example QMS, of a made-up company and its device, illustrating how to customise the SoftComply eQMS for your specific needs.
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Features

Compliant
SoftComply eQMS is compliant with both FDA and MDR Regulations - it has a Quality Manual, a Quality Policy, 22 SOPs and 77 document templates pre-filled to fast-track the development and implementation of your QMS. Just add your company and product development details!
Customisable
SoftComply eQMS is fully customisable to any medical device development project. You can easily copy QMS templates into other project spaces that need to comply with your Quality System requirements – quickly managing the QMS requirements in various projects you run!
Integration
SoftComply eQMS is fully integrated to Atlassian Confluence. Additional integration with the Comala Document Management app will extend it to a full Cloud eQMS Solution for Confluence.

How it works

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SoftComply eQMS

Benefits

The Most Affordable QMS
SoftComply eQMS is the most affordable way to implement a Compliant QMS in an medical device company!
The only QMS App on Confluence
Your QMS is a designated Space in your company’s Confluence – home to all of your QMS related documents. QMS Content can easily be extended into a full eQMS Solution.
Full Compliant Content
The SoftComply eQMS comes with a full sample QMS that provides a full exemplary QMS of a sample company – your guide to finalising your own QMS documentation.

FAQ

How can I learn more about the eQMS?

For a full product or the extended eQMS Solution demo, please book a DEMO CALL with us at a time that suits you best. In the demo, we will walk you through the entire content and features of the eQMS.

For recorded session, please check out our YouTube playlist about the eQMS Solution on Confluence.

Why are some SOPs and Templates empty?

The Trial version of the SoftComply eQMS contains the full structure of a QMS, but not all content is available in the Trial mode. You can access the entire content of the eQMS by purchasing the full license.

What happens when my evaluation period ends?

When your evaluation period ends and you did not purchase the license, the SoftComply eQMS’ functionality will stop working. Any Trial space deployed during the evaluation will still be available but it will not be possible to create any additional Trial QMS spaces and the macros will not be working.

What happens if I decide not to renew the license?

Any QMS space that you have already deployed will not be affected, but it will not be possible to create any additional QMS spaces and the macros will stop working.
If you choose to purchase the license, all features will become available again.

What standards is the SoftComply eQMS based on and where can I find them?

SoftComply eQMS is based on the latest version of: ISO 13485:2016, IEC 62304:2006 (as amended in 2008 and 2015), ISO 14971:2012 and 21 CFR 820.

I need help to customize my eQMS!

Visit the SoftComply website and get in touch with us. We will be happy to support you! Contact us at info@softcomply.com or book a call with us in our demo calendar.

We also have an extensive network of consultants who can provide dedicated and professional support.

Book a Demo Call


SOFTCOMPLY eQMS ON
Atlassian

SoftComply eQMS is a Quality Management System packaged as an app on Confluence.

Compliant with both the FDA & the MDR Regulations.