The Gist of Writing Better Read And Understood Training Docs

Posted on Posted in Confluence, Electronic QMS, General, Training Genius PlugIn

Getting 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 Practices

Posted on Posted in Confluence, Electronic QMS, General, Training Genius PlugIn

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 to be obscure and boring. The temptation to find a shortcut and skip bits of essential learning just to get […]

In order to strike the balance, you must understand the difference between "stories" (Agile term) and "specifications" (Design Controls term).

Agile and design controls: From story to specifications

Posted on Posted in Electronic QMS, JIRA, Validation microsite

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 “stories” (Agile term) and “specifications” (Design Controls term). From my experience […]

Why should quality assurance be difficult and awkward? Take a strategic view on achieving compliance (focus on ISO 13485)

Posted on Posted in Electronic QMS, General

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 […]