• eQMS

SoftComply eQMS

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FEATURES:

Full Quality Management System

SoftComply eQMS has a Quality Manual, a Quality Policy, 17 SOPs and 45 document templates pre-filled to fast-track the development and implementation of your QMS. Just add your company and product development details!

 

Customizable

SoftComply eQMS is fully customizable to any medical device development project.

 

Integration

SoftComply eQMS is fully integrated to Atlassian Confluence.

 

Embedded Guidance

SoftComply eQMS contains embedded guidance on how to customize the SOPs and technical documents according to your company and the device.

 

Full Example QMS

SoftComply eQMS contains a completed Quality Management System, an Example QMS, of a made-up company and its device, illustrating how to customize the SoftComply eQMS for your specific needs.

 

Compliance in all projects

SoftComply eQMS provides a home for all QMS documentation as a space in Atlassian Confluence. 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!

 

BENEFITS:

 

Supports FDA and CE-marking

SoftComply eQMS is comprehensively focused on the EU and US markets helping users fulfill their requirements for ISO 13485, IEC 62304, ISO 14971, 21 CFR 820.

 

First Quality Management System add-on for Atlassian

Your QMS is a designated Space in your company’s Confluence – home to all of your QMS related documents.

 

Reduces the Cost of Compliance

The SoftComply eQMS comes with a full sample QMS that provides a full exemplary QMS of a sample company – your guide to finalizing your own QMS documentation.

 

Most Competitive Price

Ask for the SoftComply eQMS annual license fee for your organization or about the SoftComply eQMS for Confluence Cloud:

 

 

The majority of our clients are from USA, UK, rest of Europe
&
they include startups as well as Fortune 500 companies.

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You can learn more about how to use the SoftComply eQMS from the User Guide.