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 | Mar 20, 2020 | Electronic QMS, General, JIRA
One of the “free wins” that quality managers get when they put their QA processes in Jira is the opportunity to use Kanban boards. This agile project management tool helps teams visualize work and improve efficiencies. Where quality processes tend to be obscure with... 
by Rina Nir | Aug 12, 2018 | Electronic QMS, JIRA
These are exciting times to serve the life sciences sector – thanks to technological advances, innovations abound and progress marches on at a lightening-fast clip. Working with a wide variety of organisations, I see two very different types of teams searching... 
by Rina Nir | Apr 18, 2018 | Confluence, Electronic QMS, JIRA
If you’ve ever wandered into a popular juice bar and decided to consume your favorite pressed beverage on-site, you may have noticed a few interesting aspects of the shop’s management that resonate with your role as a quality manager: Juice bars are... 
by Rina Nir | Apr 3, 2018 | Electronic QMS, JIRA, Validation microsite
Over the course of working with dozens of innovative, exceptional companies, I’m always struck by their commonalities of purpose and process. While they all are creating products poised to help us all live happier, healthier and more productive lives, ironically... 
by Rina Nir | Mar 19, 2018 | Electronic QMS, JIRA
If you need to maintain information for an FDA inspection or submission, Jira is a great tool to use. Be aware, however, that the Code of Federal Regulations Title 21, part 11 requires you to be able to export that data from the system into a readable, precise... 