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 […]
In the beginning there was the SOP. Then a form was created to collect all the necessary data and signatures to prove that the SOP was followed. Then people forgot why the process was developed in the first place, because as long as they filled in the form properly, all would be compliant. But is […]
Cambridge, UK, 12 October 2015: RadBee Ltd, which specializes in providing software solutions for quality assurance in the medtech, biotech and pharmaceutical industries, has been approved as an Atlassian Expert. This means that RadBee is endorsed to sell licenses for the Atlassian Jira and Confluence collaboration products to “unleash the potential in every team”. They […]
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 […]
While Jira is already a great platform for issue tracking and business process management, we find that boosting it with plugins makes it much more useful for quality management purposes. Here we list some of our favourites and explain the value they add. Note: At the time of writing, all these plugins are only available […]
wiki /ˈwɪki/ noun A website or database developed collaboratively by a community of users, allowing any user to add and edit content. source: Oxford Dictionaries Incorporating a wiki into your intranet is an excellent way to help everyone stay up-to-date with your standard operating procedures (SOPs). Here are a few of the reasons why: Anyone […]
Quality Assurance is not a one person or one team business. In exactly the same way that budget control is not only the CFO’s business, keeping a whole organization in compliance cannot be achieved by the QA team acting on its own. The QMS (Quality Management System) of an organization has an impact on most […]
Recently I was invited to give a Process V&V presentation at the Medtec UK conference in London. My challenge was to create a presentation which is accessible to an audience with very different backgrounds: I wanted to introduce the newbies to the subject but have enough meat to keep the experts. My solution was to […]
It is all too easy to dive into the list of requirements contained within the ISO 13485 and achieve compliance by just ticking the boxes: looking at one requirement or one area at a time and making sure you have put in place something to address that requirement. This may easily result in a quality […]