by Rina Nir | Apr 16, 2020 | Electronic QMS, General, JIRA
Quality Assurance processes often require holding reviews and documenting decisions made by stakeholders. Common examples include CAPAs Review Board, Complaints Review Board, and Design Review. There’s a misconception that for regulatory purposes, the results of... 
by Rina Nir | Aug 10, 2019 | 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... 
by Rina Nir | Jul 21, 2019 | 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... 
by Rina Nir | Mar 5, 2018 | 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... 
by Rina Nir | Sep 10, 2015 | Electronic QMS, JIRA
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... 