3 MUST-HAVE AREAS TO CONSIDER WHEN SETTING YOUR ORGANIZATION UP ON ATLASSIAN STACK

3 things regulated industries must consider when setting up their organisations on Atlassian Jira and Confluence

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New in SoftComply Risk Manager on Jira Cloud

In addition to being able to apply the SoftComply Risk Manager to any Jira projects – the new feature of the Risk Manager on Jira Cloud we released in December 2020, there are another two new features we released just now. NEW RISK PROJECT CREATION WIZARD When you are creating a new risk project with […]

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Top 3 Features of an Electronic Document Management System for Medical Devices

As all the rest of your work has moved from manual to electronic, your Document Management System (DMS) should also be fully electronic. Preferably on the same platform you are using for the rest of your medical device development related work. For example, if your software development team is using Jira, it is only natural […]

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How to apply SoftComply Risk Manager features to any Jira project

Wouldn’t it be cool to keep everything in Jira – your backlog, your test cases and your risks all in Jira? Yes, but you could do that for years already. But what if all that can be done in a single Jira project? That would be truly awesome! You can now do it with the […]

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How to Add Page Numbers to the PDF Exports of Quality Records in Confluence

Paper-based Quality Management Systems are now (almost) a thing of the past (it’s sooo 20th century…). But in some cases, printing records and documents from the eDMS is necessary, or at least exporting them to PDF. The requirements for paper documents are the same as digital documents. But, unlike electronic formats, physical misplacement or loss […]

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Medical Device Compliance & Atlassian Cloud

On the 16th of October 2020, Atlassian announced radical changes to their offering. From February 2nd 2021, Atlassian will not sell any new Server licenses for any of their products. A year later, in February 2022, it will not be possible to upgrade or downgrade your Atlassian Server product tier. From February 2023, it will […]

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How to Use Confluence Pages as Templates

Summary SoftComply has released a new Confluence Server macro within the SoftComply eQMS app that allows the user to use any Confluence page as a template, copying it automatically into the existing space at a click of a button. Features include the addition of prefixes, suffixes, timestamp and more. This bypasses the use of Confluence […]

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What is a Risk Management File?

ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that are produced by risk management”. In practice, the risk management file must contain, or have reference to, the following documents: (4.2, Note 3) The policy for establishing criteria for risk acceptability. (4.4) The Risk Management Plan. (4.5) Traceability for […]

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Comparison of SoftComply eQMS & MediCompli Solution

What is a Quality Management System? You probably know that Medical Device companies are required to have a Quality System in place, in order to be able to market their products in most countries in the world. This Quality System, or Quality Management System – QMS, is a collation of Procedures, documents, templates and records […]

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