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 […]

Process mapping

Posted on Posted in Validation microsite

Whenever a new computer system is introduced or an old one updated, the goal is to better support one or more processes. For example, a document management system facilitates the process of authoring and approving documents while a service desk application streamlines the process of receiving and handling support requests. Before embarking on any project […]

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. […]

Writing clear SOPs is difficult because they serve two distinct audiences: your internal team that has to execute the procedures, and the auditor who reviews them to ensure compliance. The trick is to strike a balance in the content, style, and organisation so they're easily understood by anyone who reads them.

Four strategies to ensure your standard operating procedures are easy to read

Posted on Posted in JIRA

Standard Operating Procedures (SOPs) are necessary for any efficient system, and yet their effectiveness can vary widely based on how well – or not – the procedures are written. Writing clear SOPs is difficult because they serve two distinct audiences: your internal team that has to execute the procedures, and the auditor who reviews them to ensure compliance. […]

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 […]

Why the controlled document lifecycle matters

Why the controlled document lifecycle matters

Posted on Posted in Confluence

Often, when life sciences companies are working to define their controlled document management process, they spend a lot of time considering the regulations and ensuring that their approval process and electronic signatures are compliant. However, the regulations don’t require the process to be easy or efficient, and prioritising compliance over practicality often results in cumbersome […]