A compliant QMS content conforming to ISO 13485, IEC 62304, ISO 14971 and 21 CFR 820, and growing.

We have put together a full QMS - you will find here a Quality Manual that explains how the QMS is organized; a Quality Policy - a brief statement about your organization’s purpose and strategic direction and a commitment for achieving the quality objectives; a set of written Procedures (20 SOPs) and more than 70 Technical Document Templates.

But what about the “e” in the eQMS?

It stands for everything electronic in the quality management system - the electronic workflows, electronic signatures, macros and automatically populated reports that will help you automate your activities and have a better oversight of your product quality.

Configuring your Confluence Cloud instance for Compliance.

Confluence is a great space for document management and collaboration but it comes pretty empty at first. To have the quickest start and to adopt the best practices gathered from our experience, we recommend our customers to have the Cloud eQMS setup done by us. This is the quickest way to have everything properly set up and obtain the advanced workflows and useful macros to make your quality management system electronic.

More support from SoftComply - validation of the Cloud eQMS Solution.

SoftComply provides validation support as a service to medical device and other safety critical domain companies. We can provide you with the validation protocol of the Cloud eQMS Solution - test cases that you can use for in-house testing. Alternatively, we can also run the first validation of the entire Cloud eQMS Solution in your Confluence instance for you and provide you with a complete validation package as a result.

Benefits of the SoftComply eQMS:

Benefits of the SoftComply Risk Manager PLUS for Jira Server & Data Center:

Benefits of the SoftComply Risk Manager for Confluence: