Markus Roemer, in Stuttgart, puts order in the GXP regulatory landscape

Stuttgart Summit: Highlights & takeaways on how to validate software development tools for GXP and MedDev

Posted on Posted in Confluence, Electronic QMS, JIRA, Validation microsite

Last week a select group of 15 health sector professionals representing businesses from startups to large pharmaceutical companies gathered in Stuttgart, Germany for expert insights on implementing and maintaining effective quality systems. Featuring presentations by four industry leaders, attendees left the conference with actionable information – regardless of if they were initiating a new system […]

RadBee Sophia Genetics Case Study

From Paper-Based to practical: How we digitised a paper-based QMS & ensured ISO-27001 compliance in just 5 weeks

Posted on Posted in Case studies, Confluence, Electronic QMS

An efficient quality management system (QMS) is the lifeblood of any company in the health industry. Failure to meet strict regulatory and compliance requirements could mean lost business or even a complete shutdown of operations. The challenge Biotech start-up SOPHiA GENETICS has had a QMS in place since its launch six years ago. VP of […]

How to validate Software Development tools used for GXP and MedDev?

Validating software development tools used for GxP and MedDev

Posted on Posted in 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 guidelines might be applied to the design of the software development lifecycle (SDLC) and the validation of software, like […]

How to Easily Create a Compliance Table in Confluence

How to create a compliance table in Confluence

Posted on Posted in 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 table. It gives them immediate access to answers about how you apply particular standard directives. […]

Before you build a Quality Management System (QMS), it’s critical that you understand what is your key driver.

What you should ask yourself before building a quality management system

Posted on Posted in 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 mark, FDA approval). We’re “forced” to have one. We’re about to […]

Two new things we love in Confluence

Two new things we love in Confluence

Posted on Posted in 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 plugin that provides better control over reused content. The second is […]

How Confluence meets the needs of document users?

How Confluence meets the needs of document users

Posted on Posted in 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 each of our quality management projects. The list below shows how a document management […]