4 Smart lessons quality managers can squeeze out of a juice bar
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...
Heading toward hands-free validation
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...
The art of creating complete & accurate records for FDA inspections from 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...
Agile and design controls: From story to specifications
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...
Stuttgart Summit: Highlights & takeaways on how to validate software development tools for GXP and MedDev
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...More from RadBee
How Agile Teams Can Avoid Being Victims of Their Post-it HabitsAs an eQMS specialist who frequently works with agile teams, I often walk away from meetings thinking, “Boy, do I wish I owned stock in 3M, the original makers of post-it notes!” While post-its are famously used for design sprints, their versatility makes them a naturally powerful brainstorming tool for agile teams. It was at […]
The Gist of Writing Better Read And Understood Training Docs, Part 2Read & Understood trainings are known both for what they do well — demonstrate compliance to auditors — and also for what they do not do so well: truly train employees. The truth is there’s no reason that you can’t achieve both goals by making it quick and easy for trainees and auditors alike to […]
What does eQMS success looks like?A successful eQMS project is not simply about replacing a legacy tool with a shiny, cool new one. It’s also not solely about achieving regulatory compliance. While those are positive outcomes, they’re not the point of evolving your quality system. Just like smart phones weren’t only an upgrade of the dial telephone and commercial flights […]
The Gist of Writing Better Read And Understood Training DocsGetting 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 PracticesStandard 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 […]