Why the Way to a Hellish Quality System May Be Paved With Best Practices
Standard operating procedures (SOPs) created according to “best practices” ideally should lead to smooth, coordinated operations, greater productivity, lower risk of errors and better compliance. But oftentimes, the reality is different. Regulations and standards tend...
Agile and design controls: From story to specifications
Doing Agile in a GXP or medical devices environment requires you to serve two masters: you need to practice the Agile disciplines on one side, and embrace regulatory requirements on the other. In order to strike the balance, you must understand the difference between...
Jira plugins for quality management
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...
Why should quality assurance be difficult and awkward? Take a strategic view on achieving compliance (focus on ISO 13485)
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...More from RadBee
The Gist of Writing Better Read And Understood Training Docs, Part 2Read & Understood trainings are known both for what they do well — demonstrate compliance to auditors — and also for what they do not do so well: truly train employees. The truth is there’s no reason that you can’t achieve both goals by making it quick and easy for trainees and auditors alike to […]
What does eQMS success looks like?A successful eQMS project is not simply about replacing a legacy tool with a shiny, cool new one. It’s also not solely about achieving regulatory compliance. While those are positive outcomes, they’re not the point of evolving your quality system. Just like smart phones weren’t only an upgrade of the dial telephone and commercial flights […]
The Gist of Writing Better Read And Understood Training DocsGetting your team to confirm they’ve read and understood documents is only half the battle. Granted, it’s an important battle to win. It’s why we love getting feedback like this on our Read & Understood Training Genius app for Confluence: “It’s great — one of our developers was behind with 69 read & understood trainings. […]
Why the Way to a Hellish Quality System May Be Paved With Best PracticesStandard operating procedures (SOPs) created according to “best practices” ideally should lead to smooth, coordinated operations, greater productivity, lower risk of errors and better compliance. But oftentimes, the reality is different. Regulations and standards tend to be obscure and boring. The temptation to find a shortcut and skip bits of essential learning just to get […]
How to Easily Integrate Radbee’s Read & Understood Training Genius With Comala AppsIf you are using Comala Workflows App to manage your controlled documents, then your “read and understood” rules should be aware of the workflow status of the page. For example, if you would like people to train on pages that have a new official version, which is about to or has recently gone into effect, […]