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...
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 | Feb 14, 2018 | Confluence, Electronic QMS, JIRA, Validation microsite
Last week a select group of 15 health sector professionals representing businesses from startups to large pharmaceutical companies gathered in Stuttgart, Germany for expert insights on implementing and maintaining effective quality systems. Featuring presentations by...