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 […]

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 […]

Comala workflow can be implemented to address FDA and other regulatory needs.

Using Comala Workflows for approval of controlled documents

Posted on Posted in Confluence, Electronic QMS, JIRA

When considering using Confluence to develop and release controlled documents, one of the main concerns many companies have is whether they will be able to approve the documents directly from the application. This is possible using Comalatech’s Comala Workflows plugin, which allows us to configure your desired approval workflow right into Confluence. This plugin has […]

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 […]