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 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... 
by Rina Nir | Dec 19, 2017 | Electronic QMS, JIRA, Validation microsite
Without the right tools in place, traceability matrices can easily bring a project to the brink of collapse. Still today there are project managers who delay moving to production for a significant length of time while they put together a traceability matrix for the... by Rina Nir | Oct 29, 2017 | Validation microsite
When teams set out to determine the requirement specifications for a computerised system, confusion often arises. However there are some simple steps you can take that will help you build up a clear picture of the requirements along with getting buy-in from everyone... by Rina Nir | Oct 29, 2017 | Validation microsite
Whenever a new computer system is introduced or an old one updated, the goal is to better support one or more processes. For example, a document management system facilitates the process of authoring and approving documents while a service desk application streamlines... 