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 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 […]

Versioning controlled documents in Confluence

Controlled documents: versioning in Confluence

Posted on Posted in Confluence, Electronic QMS, General, JIRA

Confluence comes with built-in document version management. Each time a document is modified then saved, a new version is added to the history and automatically tagged with a version number, starting at v.1, then progress through v.2, v.3, etc. This innate versioning mechanism provides a host of features: The document history is easily accessible through […]