We’re proud to announce a new collaboration between RadBee and comes compliance services (CCS). Based in Ravensburg, Germany, CCS is a specialist IT quality assurance and regulatory affaires consultancy company that applies innovative IT solutions to supports clients in regulated industries, including pharmaceutical and medical device companies across the globe. Experts in computer system validation, […]
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 […]
Everything is streamlined, and the time savings have been incredible. Now, compliance-related tasks are getting done in 1/5th the time they used to take.
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 […]
One of the most common concerns with the implementation of new operational software is the effort involved in migrating the existing data to the new system. I just recently had an opportunity to show off how easy and immediate this is with JIRA®. The pharma distributor used Excel to manage the records related 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 […]