by Rina Nir | Oct 8, 2017 | Confluence, Electronic QMS, General, JIRA
Compliance is a key consideration when using software tools in the context of: Development of software applications which are used for good practice (GxP) purposes Development of software and hardware embedded on medical devices (MedDev). Several standards and... 
by Rina Nir | Sep 24, 2017 | Confluence
When building a quality procedure that complies with a specific standard, a compliance table is a handy reference. It maps the standards’ sections to your procedures, and helps ensure that all requirements are met. As an added benefit, auditors love a compliance... 
by Rina Nir | Aug 28, 2017 | Confluence, Electronic QMS, JIRA
Before you build a quality management system (QMS), it’s critical that you understand what is your key driver. Over the years, here are some of the motives I’ve heard: It’s a milestone for the next funding round. It satisfies regulatory requirements (i.e. CE... 
by Rina Nir | Apr 22, 2017 | Confluence, Electronic QMS, General, JIRA
People often ask me about the specific roles different Atlassian tools play in supporting quality management processes. Here I’ve put together a few examples of which tools are best to support each aspect of certain quality management processes and why. While the... 
by Rina Nir | Oct 2, 2016 | Confluence
The Atlassian tools and third-party plugins for Confluence are evolving all the time and at RadBee we’re always on the lookout for changes that might help to support your compliance and quality assurance needs. We’ve recently come across two gems. The first is a... 
by Rina Nir | Mar 18, 2016 | Confluence, Electronic QMS
When designing a controlled document management system, it’s important to take the requirements of everyone who may need to access the documents into account. That’s why mapping users’ needs through each stage of the controlled document lifecycle is a key element in... 